Granted Patent
B2
US 12,522,645 · App. 17/088,845 · Granted Jan 13, 2026
BCMA-targeted CAR-T cell therapy of multiple myeloma
Inventors:
Enrique Zudaire Ubani (Ambler, PA); Xiaohu Fan (Edmonton, CA); Dong Geng (Somerset, NJ); Jordan Mark Schecter (Livingston, NJ)
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Abstract
Provided herein is a method of treating a subject who has a cancer. At least one dose of chimeric antigen receptor (CAR)-T cells comprising a CAR comprising a polypeptide is administered to the subject. The peptide comprises an extracellular antigen binding domain with at least two BCMA-binding moieties, a transmembrane domain, and an intracellular signaling domain. The dose of CAR-T cells administered to the subject is from 4.0×10 5 to 1.0×10 6 of CAR-T cells per kilogram of the subject's mass. Alternatively, the dose comprises 1×10 6 to 1×10 8 of the CAR-T cells.
Claims (128)
1 . A method of treating a subject who has a cancer, comprising administering to the subject a dose of cells comprising a chimeric antigen receptor (CAR) polypeptide comprising:
a) an extracellular antigen binding domain comprising a first B-cell maturation antigen (BCMA) binding moiety and a second BCMA binding moiety;
b) a transmembrane domain; and
c) an intracellular signaling domain,
wherein the cells are T cells,
wherein the first BCMA binding moiety comprises the amino acid sequence of
(SEQ ID NO: 1)
QVKLEESGGGLVQAGRSLRLSCAASEHTFSSHVMGWFRQAPGKERESVAV
IGWRDISTSYADSVKGRFTISRDNAKKTLYLQMNSLKPEDTAVYYCAARR
IDAADFDSWGQGTQVTVSS,
wherein the second BCMA binding moiety comprises the amino acid sequence of
(SEQ ID NO: 3)
EVQLVESGGGLVQAGGSLRLSCAASGRTFTMGWFRQAPGKEREFVAAISL
SPTLAYYAESVKGRFTISRDNAKNTVVLQMNSLKPEDTALYYCAADRKSV
MSIRPDYWGQGTQVTVSS,
wherein the cancer is refractory or relapsed multiple myeloma,
wherein the dose comprises 5.0×10 5 to 1.0×10 6 of the T cells per kilogram of the mass of the subject,
wherein the method comprises administering to the subject a single dose of the T cells by infusion during the course of the treatment, and
wherein the subject has received multiple prior lines of therapy comprising a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
2 . The method of claim 1 , wherein the cells are expanded in vitro prior to infusion.
3 . The method of claim 1 , wherein the T cells are heterologous T cells.
4 . The method of claim 1 , wherein the dose comprises 5.5×10 5 to 8×10 5 of the T cells per kilogram of the mass of the subject.
5 . The method of claim 1 , wherein the dose comprises about 7.5×10 5 of the T cells per kilogram of the mass of the subject.
6 . The method of claim 1 , wherein the dose comprises 1×10 6 to 1×10 8 of the total amount of the T cells.
7 . The method of claim 1 , wherein the dose comprises 2×10 7 to 8×10 7 of the total amount of the T cells.
8 . The method of claim 1 , wherein the dose comprises about 5.25×10 7 of the total amount of the T cells.
9 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in 5.0×10 5 to 1.0×10 6 of the T cells per kilogram of the mass of the subject.
10 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in 5.5×10 5 to 8×10 5 of the T cells per kilogram of the mass of the subject.
11 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in about 7.5×10 5 of the T cells per kilogram of the mass of the subject.
12 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in 1×10 6 to 1×10 8 of the T cells in the subject.
13 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in 2×10 7 to 8×10 7 of the T cells in the subject.
14 . The method of claim 1 , wherein the method comprises administering the dose of the T cells resulting in about 5.25×10 7 of the T cells in the subject.
15 . The method of claim 1 , wherein the method comprises administering the dose of the T cells intravenously.
16 . The method of claim 1 , wherein the T cells comprise CD4+T cells and CD8+T cells and a ratio of the CD4+T cells to the CD8+T cells to CD8+T cells in the dose of the T cells is less than 4.
17 . The method of claim 16 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 2.
18 . The method of claim 17 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.8.
19 . The method of claim 18 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.7.
20 . The method of claim 19 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.6.
21 . The method of claim 20 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.4.
22 . The method of claim 21 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.2.
23 . The method of claim 22 , wherein the ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is less than 1.0.
24 . The method of claim 1 , wherein the T cells comprise CD4+T cells and CD8+T cells and a ratio of CD4+T cells comprising the CAR polypeptide at Cmax to CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 3.5.
25 . The method of claim 1 , wherein the T cells comprise CD4+T cells and CD8+T cells and a ratio of CD4+T cells comprising the CAR polypeptide at Cmax to CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 2.0.
26 . The method of claim 25 , wherein the ratio of the CD4+T cells comprising the CAR polypeptide at Cmax to the CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 1.2.
27 . The method of claim 26 , wherein the ratio of the CD4+T cells comprising the CAR polypeptide at Cmax to the CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 0.8.
28 . The method of claim 27 , wherein the ratio of the CD4+T cells comprising the CAR polypeptide at Cmax to the CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 0.6.
29 . The method of claim 28 , wherein the ratio of the CD4+T cells comprising the CAR polypeptide at Cmax to the CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 0.4.
30 . The method of claim 29 , wherein the ratio of the CD4+T cells comprising the CAR polypeptide at Cmax to the CD8+T cells comprising the CAR polypeptide at Cmax in the subject is less than 0.3.
31 . The method of claim 1 , wherein the first BCMA binding moiety and/or the second BCMA binding moiety is an anti-BCMA single domain antibody (sdAb).
32 . The method of claim 31 , wherein the first BCMA binding moiety is a first anti-BCMA sdAb and the second BCMA binding moiety is a second anti-BCMA sdAb.
33 . The method of claim 1 , wherein the first BCMA binding moiety comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 2)
CAGGTCAAACTGGAAGAATCTGGCGGAGGCCTGGTGCAGGCAGGACGGAG
CCTGCGCCTGAGCTGCGCAGCATCCGAGCACACCTTCAGCTCCCACGTGA
TGGGCTGGTTTCGGCAGGCCCCAGGCAAGGAGAGAGAGAGCGTGGCCGTG
ATCGGCTGGAGGGACATCTCCACATCTTACGCCGATTCCGTGAAGGGCCG
GTTCACCATCAGCCGGGACAACGCCAAGAAGACACTGTATCTGCAGATGA
ACAGCCTGAAGCCCGAGGACACCGCCGTGTACTATTGCGCAGCAAGGAGA
ATCGACGCAGCAGACTTTGATTCCTGGGGCCAGGGCACCCAGGTGACAGT
GTCTAGC.
34 . The method of claim 1 , wherein the second BCMA binding moiety comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 4)
GAGGTGCAGCTGGTGGAGAGCGGAGGCGGCCTGGTGCAGGCCGGAGGCTC
TCTGAGGCTGAGCTGTGCAGCATCCGGAAGAACCTTCACAATGGGCTGGT
TTAGGCAGGCACCAGGAAAGGAGAGGGAGTTCGTGGCAGCAATCAGCCTG
TCCCCTACCCTGGCCTACTATGCCGAGAGCGTGAAGGGCAGGTTTACCAT
CTCCCGCGATAACGCCAAGAATACAGTGGTGCTGCAGATGAACTCCCTGA
AACCTGAGGACACAGCCCTGTACTATTGTGCCGCCGATCGGAAGAGCGTG
ATGAGCATTAGACCAGACTATTGGGGGCAGGGAACACAGGTGACCGTGAG
CAGC.
35 . The method of claim 1 , wherein the first BCMA binding moiety and the second BCMA binding moiety are connected to each other via a peptide linker.
36 . The method of claim 35 , wherein the peptide linker comprises the amino acid sequence of GGGGS (SEQ ID NO: 5).
37 . The method of claim 1 , wherein the CAR polypeptide further comprises a signal peptide located at the N-terminus of the polypeptide.
38 . The method of claim 37 , wherein the signal peptide is derived from CD8a.
39 . The method of claim 38 , wherein the signal peptide comprises the amino acid sequence of
(SEQ ID NO: 6)
MALPVTALLLPLALLLHAARP.
40 . The method of claim 38 , wherein the signal peptide comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 7)
ATGGCTCTGCCCGTCACCGCTCTGCTGCTGCCTCTGGCTCTGCTGCTGCA
CGCTGCTCGCCCT.
41 . The method of claim 1 , wherein the transmembrane domain comprises the amino acid sequence of IYIWAPLAGTCGVLLLSLVITLYC (SEQ ID NO: 8).
42 . The method of claim 1 , wherein the transmembrane domain comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 9)
ATCTACATCTGGGCGCCCTTGGCCGGGACTTGTGGGGTCCTTCTCCTGTC
ACTGGTTATCACCCTTTACTGC.
43 . The method of claim 1 , wherein the intracellular signaling domain comprises a primary intracellular signaling domain of an immune effector cell.
44 . The method of claim 1 , wherein the intracellular signaling domain is derived from CD3ζ.
45 . The method of claim 1 , wherein the intracellular signaling domain comprises one or more co-stimulatory signaling domains.
46 . The method of claim 45 , wherein the intracellular signaling domain comprises the amino acid sequence of
(SEQ ID NO: 10)
RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPR
RKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDT
YDALHMQALPPR.
47 . The method of claim 45 , wherein the intracellular signaling domain comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 11)
AGAGTGAAGTTCAGCAGGAGCGCAGACGCCCCCGCGTACCAGCAGGGCCA
GAACCAGCTCTATAACGAGCTCAATCTAGGACGAAGAGAGGAGTACGATG
TTTTGGACAAGAGACGTGGCCGGGACCCTGAGATGGGGGGAAAGCCGAGA
AGGAAGAACCCTCAGGAAGGCCTGTACAATGAACTGCAGAAAGATAAGAT
GGCGGAGGCCTACAGTGAGATTGGGATGAAAGGCGAGCGCCGGAGGGGCA
AGGGGCACGATGGCCTTTACCAGGGTCTCAGTACAGCCACCAAGGACACC
TACGACGCCCTTCACATGCAGGCCCTGCCCCCTCGCTAA.
48 . The method of claim 45 , wherein the intracellular signaling domain comprises the amino acid sequence of
(SEQ ID NO: 12)
KRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCEL.
49 . The method of claim 45 , wherein the intracellular signaling domain comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 13)
AAACGGGGCAGAAAGAAACTCCTGTATATATTCAAACAACCATTTATGAG
ACCAGTACAAACTACTCAAGAGGAAGATGGCTGTAGCTGCCGATTTCCAG
AAGAAGAAGAAGGAGGATGTGAACTG.
50 . The method of claim 1 , wherein the CAR polypeptide further comprises a hinge domain located between the C-terminus of the extracellular antigen binding domain and the N-terminus of the transmembrane domain.
51 . The method of claim 50 , wherein the hinge domain comprises the amino acid sequence of TTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACD (SEQ ID NO: 15).
52 . The method of claim 50 , wherein the hinge domain comprises a polypeptide encoded by the nucleic acid sequence of
(SEQ ID NO: 14)
ACCACGACGCCAGCGCCGCGACCACCAACACCGGCGCCCACCATCGCGTC
GCAGCCCCTGTCCCTGCGCCCAGAGGCGTGCCGGCCAGCGGCGGGGGGCG
CAGTGCACACGAGGGGGCTGGACTTCGCCTGTGAT.
53 . The method of claim 1 , wherein the T cells are autologous T cells.
54 . The method of claim 1 , wherein the T cells are allogeneic T cells.
55 . The method of claim 1 , wherein the subject is human.
56 . The method of claim 1 , wherein the T cells comprise CD4+T cells and CD8+T cells and a ratio of the CD4+T cells to the CD8+T cells in the dose of the T cells is at a median of about 1.5.
57 . The method of claim 1 , wherein the T cells comprise CD4+T cells and CD8+T cells and a central memory T cell (Tcm) phenotype of the CD8+T cells is predominant in the CD8+T cells comprising the CAR polypeptide in the subject after administering to the subject the T cells.
58 . The method of claim 57 , wherein a ratio of the Tem CD8+T cells in the CD8+T cells comprising the CAR polypeptide in the subject ranges from about 29% to about 99%.
59 . The method of claim 58 , wherein the ratio of the Tem CD8+T cells in the CD8+T cells comprising the CAR polypeptide in the subject is at a median of about 90%.
60 . The method of claim 57 , further wherein an effector memory T cell (Tem) phenotype of the CD4+T cells in the CD4+T cells comprising the CAR polypeptide in the subject is predominant.
61 . The method of claim 60 , wherein a ratio of the Tem CD4+T cells in the CD4+T cells comprising the CAR polypeptide in the subject ranges from about 70% to about 98%.
62 . The method of claim 61 , wherein the ratio of the Tem CD4+T cells in the CD4+T cells comprising the CAR polypeptide in the subject is at a median of about 87%.
Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 4, 2025
From: GENG, DONG
To: LEGEND BIOTECH USA INC.
Reel/Frame 072783/0014 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 4, 2025
From: FAN, XIAOHU
To: NANJING LEGEND BIOTECH CO., LTD.
Reel/Frame 072782/0998 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 4, 2025
From: NANJING LEGEND BIOTECH CO., LTD.
To: LEGEND BIOTECH USA INC.
Reel/Frame 073463/0408 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 31, 2025
From: JANSSEN RESEARCH & DEVELOPMENT, LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 072754/0577 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 31, 2025
From: SCHECTER, JORDAN MARK
To: JANSSEN RESEARCH & DEVELOPMENT, LLC
Reel/Frame 072754/0574 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 30, 2021
From: UBANI, ENRIQUE ZUDAIRE
To: JANSSEN RESEARCH & DEVELOPMENT, LLC
Reel/Frame 057330/0231 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 30, 2021
From: JANSSEN RESEARCH & DEVELOPMENT, LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 057330/0295 →
Continuity (3)
Provisional Application
62943627
· Dec 4, 2019
Provisional Application
62931065
· Nov 5, 2019
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Cohen et al., 2021, “Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucelin Relapsed/Refractory Multiple Myeloma,” presented at the 47th Annual Meeting of the E…
[cited by applicant]
Cohen et al., 2021, “Patient Expectations and Perceptions of Treatment in the Phase 1b/2 CARTITUDE- 1 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma,” presented at European School of Haematol…
[cited by applicant]
Cohen et al., 2021, “Patient Expectations and Perceptions of Treatment in CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel (Cilta-Cel) BCMA-Directed CAR-T Cell Therapy, in Relapsed/Refractory Multiple Myeloma …
[cited by applicant]
Cohen et al., 2021, “Efficacy and Safety of Ciltacabtagene Autoleucel, a BCMA-Directed CAR-T Cell Therapy, in Patients With Progressive Multiple Myeloma After 1-3 Prior Lines of Therapy: Initial Results From CARTITUDE-2…
[cited by applicant]
Cohen et al., 2021, “Efficacy and Safety of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen- Directed Chimeric Antigen Receptor T-cell Therapy, in Lenalidomide-Refractory Patients With Progressive Multiple Myelom…
[cited by applicant]
Cohen et al., 2022, “Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy in Lenalidomide Refractory Patients With Progressive Multiple Myeloma After 1-3 Prior Lines o…
[cited by applicant]
Cohen et al., 2022, “Safety and Efficacy of Ciltacabtagene Autoleucel (Cilta Cel), a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Patients with Multiple Myeloma (…
[cited by applicant]
Cohen et al., 2022,“Cilta-cel, a BCMA Directed CAR-T, in MM Patients After 1-3 Prior Lines of Therapy (CARTITUDE-2),” presented at the 44th Annual Meeting of the Japanese Society for Transplantation and Cellular Therapy…
[cited by applicant]
Cohen et al., 2022, “Cilta-cel, a BCMA-Directed CAR-T, in MM Patients With Early Relapse After Initial Therapy (CARTITUDE-2 Cohort B) (Encore),” presented at the 47th Annual Meeting of the Japanese Society of Melanoma (…
[cited by applicant]
Cohen et al., 2022, “Efficacy and Safety of Cilta-cel in Patients With Progressive Multiple Myeloma After Exposure to Other BCMA Targeting Agents,” presented at the 19th International Myeloma Society (IMS) Annual Meetin…
[cited by applicant]
Cohen et al., 2022, “Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (Cilta-cel) in Lenalidomide refractory Multiple Myeloma After 1-3 Prior Lines of Therapy: CARTITUDE-2 Cohort A,…
[cited by applicant]
Cohen et al., 2022, “Efficacy and Safety of Cilta-Cel in Patients With Progressive Multiple Myeloma after Exposure to Non-cellular Anti-BCMA Immunotherapy,” presented at the 64th American Society of Hematology (ASH) Ann…
[cited by applicant]
Cohen et al., 2023, “Efficacy and Safety of Cilta-Cel and T-Cell Phenotype Analyses in Patients With Relapsed/Refractory Multiple Myeloma and Prior Non-Cellular Anti-BCMA Therapy: Phase 2 CARTITUDE-2 Cohort C,” presente…
[cited by applicant]
Cook et al., 2023, “EMagine/CARTITUDE-6: DVRd Followed by Ciltacabtagene Autoleucel Versus DVRd Followed by ASCT in Newly Diagnosed Multiple Myeloma,” presented at the 2023 British Society for Haematology Annual Meeting…
[cited by applicant]
Costa et al., 2021, “Ciltacabtagene Autoleucel Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma,” presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), J…
[cited by applicant]
Costa et al., 2021, “Comparison of Ciltacabtagene Autoleucel Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma,” presented at the Annual Meeting of the European Hematology Association (…
[cited by applicant]
De Larrea et al., 2023, “Pharmacokinetic and Correlative Analysis of Ciltacabtagene Autoleucel in Patients With Lenalidomide-Refractory Multiple Myeloma in the CARTITUDE-4 Trial,” presented at the 20th International Mye…
[cited by applicant]
Decaux et al., 2022, “Ciltacabtagene autoleucel versus treatments from real-world clinical practice for triple class exposed patients with multiple myeloma: adjusted comparisons based on CARTITUDE-1 and the EMMY French …
[cited by applicant]
Delforge, et al., 2021, “CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-Cel), a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (Car-T) Cell Therapy, in Patients With Progress…
[cited by applicant]
Delforge et al., 2021, “Real-World Outcomes for Standard-Of-Care Treatments in Patients with Relapsed/Refractory Multiple Myeloma,” presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition,…
[cited by applicant]
Delforge et al., 2022, “Treatment Landscape in Relapsed/Refractory Multiple Myeloma (RRMM): Real World Outcomes for Standard-of-Care,” presented at the 48th Annual Meeting of the European Society for Blood and Marrow Tr…
[cited by applicant]
Delforge et al., 2022, “Treatments in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Real-World Outcomes for Standard of Care (SOC),” presented at the 2022 Tandem Meetings Transplantation & Cellular Therapy …
[cited by applicant]
Delforge et al., 2022, “Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Receiving Real-Life Current Standard of Care in the LocoMMotion Study,” presented at the 2022 American Society…
[cited by applicant]
Delforge et al., 2022, “Health-Related Quality of Life in the LocoMMotion Study of Real-Life Current Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma,” presented at the European Hematology Associat…
[cited by applicant]
Delforge et al., 2022, “Health-related quality of life (HRQOL) in patients with relapsed/refractory multiple myeloma (RRMM) receiving real-life standard of care (SOC) treatments: Results from the LocoMMotion study,” pre…
[cited by applicant]
Dhakal et al., 2022, “Real-world Assessment of Treatment Patterns and Outcomes in Patients With Lenalidomide-Refractory Relapsed/Refractory Multiple Myeloma From the Optum Database, ” presented at the European Hematolog…
[cited by applicant]
Dhakal et al., 2022, “Real-world Assessment of Treatment Patterns and Outcomes in Patients With Lenalidomide-Refractory RelapsedMultiple Myeloma From the Flatiron Database,” presented at the 19th International Myeloma S…
[cited by applicant]
Dhakal et al., 2022, “Real-world Treatments and Outcomes in Patients With Lenalidomide-Refractory Relapsed Multiple Myeloma Treated With 1-3 Prior Lines of Therapy, Including a PI and IMiD, From the SEER-Medicare Databa…
[cited by applicant]
Dhakal et al., 2022, “Characteristics and Outcomes in Patients with Lenalidomide-Refractory Relapsed/Refractory Multiple Myeloma Treated with 1-3 Prior Lines of Therapy: Analysis of the Individual Patient-level Data fro…
[cited by applicant]
Dhakal et al., 2023, “Phase 3 Results From CARTITUDE-4: Cilta-Cel Versus Standard of Care (PVd or DPd) in Lenalidomide-Refractory Multiple Myeloma,” presented at the Annual Meeting of the American Society of Clinical On…
[cited by applicant]
Dhakal et al., 2023, “Real-World Attrition Rates After Second-Line Therapy or Later in Patients From the Flatiron Database With Relapsed/Refractory Multiple Myeloma Refractory to Lenalidomide,” presented at the 20th Int…
[cited by applicant]
Dhakal et al., 2023, “First Phase 3 Results From CARTITUDE-4: Cilta-cel Versus Standard of Care (PVd or DPd) in Lenalidomide Refractory Multiple Myeloma,” presented at the 2023 German Society for Hematology and Medical …
[cited by applicant]
Dytfeld et al., 2021, “Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Maintenance in Patients with Newly Diagnosed Mult…
[cited by applicant]
Dytfeld et al., 2022, “Randomized, Phase 3 Study of Bortezomib, Lenalidomide and Dexamethasone Followed by Ciltacabtagene Autoleucel Versus Bortezomib, Lenalidomide and Dexamethasone Followed by Lenalidomide and Dexamet…
[cited by applicant]
Einsele et al., 2021, “CARTITUDE-2: Phase 2 Multicohort Study of Ciltacabtagene Autoleucel, a B- Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy, in Patients With Multiple Myeloma,” presented a…
[cited by applicant]
Einsele et al., 2021, “CARTITUDE-2: Phase 2 Multicohort Study of Ciltacabtagene Autoleucel (Cilta- Cel), a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (Car-T) Cell Therapy, in Patients With Mul…
[cited by applicant]
Einsele et al., 2021, “Incidence, Mitigation, and Management of Neurologic Adverse Events in Patients With Multiple Myeloma Treated With Ciltacabtagene Autoleucel in CARTITUDE-2,” presented at the Annual Meeting of the …
[cited by applicant]
Einsele et al., 2021, “Incidence, Mitigation, and Management of Neurologic Adverse Events in the Phase 2 CARTITUDE-2 Study of Ciltacabtagene Autoleucelin Patients With Multiple Myeloma,” presented at the Annual Meeting …
[cited by applicant]
Einsele et al., 2021, “Incidence, Mitigation, and Management of Neurologic Adverse Events in CARTITUDE-2, a Phase 2 Study of Ciltacabtagene Autoleucel (Cilta-Cel) in Patients with Multiple Myeloma,” presented at 18th In…
[cited by applicant]
Einsele et al., 2021, “Incidence, Mitigation, And Management Of Neurologic Adverse Events In Patients With Multiple Myeloma Treated With Ciltacabtagene Autoleucel (Cilta-Cel) In CARTITUDE-2,” presented at Brazilian Cong…
[cited by applicant]
Einsele et al., 2022, “Cartitude-2 Update: Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen- Directed Chimeric Antigen Receptor T-Cell Therapy, in Lenalidomide Refractory Patients with Progressive Multiple Myeloma…
[cited by applicant]
Einsele et al., 2022, “Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-Cel) in Lenalidomide- Refractory Patients (PTS) with Progressive Multiple Myeloma (MM) After 1-3 Prior Lines of Therapy (LOT):Cartitude-2 Up…
[cited by applicant]
Einsele et al., 2022, “Mitigation and Management of Neurologic AEs in Multiple Myeloma Patients Treated with Cilta-cel in CARTITUDE-2,” presented at the 44th Annual Meeting of the Japanese Society for Transplantation an…
[cited by applicant]
Einsele et al., 2022, “Efficacy and Safety of Cilta-cel, a BCMA-Directed CAR-T cell Therapy, in Patients With Multiple Myeloma After 1-3 Prior Lines of Therapy (Encore),” presented at the 47th Annual Meeting of the Japa…
[cited by applicant]
Einsele et al., 2022, “Biological Correlative Analyses and Updated Clinical Data of Ciltacabtagene Autoleucel, a BCMA-Directed CAR-T Cell Therapy, in Lenalidomide-Refractory Patients With Progressive Multiple Myeloma Af…
[cited by applicant]
Einsele et al., 2022, “Subgroup Analyses in Patients With Relapsed/RefractoryMultiple Myeloma Receiving Real-Life Current Standard of Carein the LocoMMotion Study,” presented at the 2022 American Society of Clinical Onc…
[cited by applicant]
Einsele et al., 2022, “Real-Life Current Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma: Subgroup Analyses From the LocoMMotion Study,” presented at the European Hematology Association (EHA) 2022…
[cited by applicant]
Einsele et al., 2022, “Subgroup analyses from the LocoMMotion study of real-life current standard of care (SOC) in patients with relapsed/refractory multiple myeloma (RRMM),” presented at the International Myeloma Socie…
[cited by applicant]
Einsele et al., 2022, “Phase 2 CARTITUDE-2 Study (Cohort A): Biological Correlative Analyses and Updated Clinical Data of Cilta-cel, a BCMA directed CAR-T Cell Therapy, in Lenalidomide refractory Patients With Progressi…
[cited by applicant]
Einsele et al., 2023, “Analysis of Daratumumab Clinical Trials: Characteristics and Outcomes in Patients With Lenalidomide-Refractory Relapsed/Refractory Multiple Myeloma Treated With 1-3 Prior Lines of Therapy,” presen…
[cited by applicant]
Einsele et al., 2023, “SEER-Medicare Database: Real-world Treatments and Outcomes in Patients With Lenalidomide-Refractory Relapsed Multiple Myeloma Treated With 1-3 Prior Lines of Therapy, Including a PI and IMiD,” pre…
[cited by applicant]
Einsele et al., 2023, “Characteristics and Outcomes in Patients With Lenalidomide-Refractory Relapsed/Refractory Multiple Myeloma Treated With 1-3 Prior Lot: Analysis of the Individual Patient- Level Data From Daratumum…
[cited by applicant]
Einsele et al., 2023, “Real-World Treatments and Outcomes in Patients With Lenalidomide-Refractory Relapsed Multiple Myeloma Treated With 1-3 Prior Lines of Therapy, Including a PI and IMID, From the Seer-Medicare Datab…
[cited by applicant]
Florendo et al., 2021, “Safety and Management of Adverse Events With Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T-Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma: Initial Results From CAR…
[cited by applicant]
Goldschmidt et al., 2021, “Adjusted Comparison of Outcomes Between Patients From CARTITUDE- 1 Versus Multiple Myeloma Patients With Prior Exposure to PI, IMiD and Anti-CD-38 From a German Registry,” presented at the EHA…
[cited by applicant]
Hajek et al., 2022, “Patient Characteristics and Survival Outcomes of Lenalidomide Exposed Non- Refractory vs Lenalidomide Refractory Multiple Myeloma Patients in the HONEUR Federated Data Network,” presented at the 64t…
[cited by applicant]
Hari et al., 2021, “Meta-analysis of Ciltacabtagene Autoleucel versus Physician's Choice in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma,” presented at the 63rd American Society of Hematology (…
[cited by applicant]
Hari et al., 2022, “Results from a Meta Analysis of Ciltacabtagene Autoleucel Compared to Physician's Choice in Patients with Relapsed or Refractory Multiple Myeloma,” presented at the 2022 Tandem Meetings - Transplanta…
[cited by applicant]
Hillengass et al., 2022, “Updated Results of CARTITUDE-2: Ciltacabtagene Autoleucel cilta-cel), a B-Cell Maturation Antigen (Directed Chimeric Antigen Receptor T Cell (CAR-T) Therapy, in Lenalidomide Refractory Patients…
[cited by applicant]
Hillengass et al., 2022, “Ciltacabtagene Autoleucelin Lenalidomide-Refractory Patients With Progressive Multiple Myeloma After 1-3 Prior Lines of Therapy: CARTITUDE-2 Biological Correlative Analyses and Updated Clinical…
[cited by applicant]
Hillengass et al., 2022, “CARTITUDE-2 Cohort A: Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel) in Lenalidomide-Refractory Patients with Progressive Multiple Myeloma (M…
[cited by applicant]
Hillengass et al., 2023, “The Phase 2 CARTITUDE-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients With Multiple Myeloma and 1-3 Prior Lines of Therapy (Cohort A) and With Early Relapse After …
[cited by applicant]
Hillengass et al., 2024, “The Phase 2 CARTITUDE-2 Update: Ciltacabtagene Autoleucel in Multiple Myeloma and 1-3 Prior Lines (Cohort A) and With Early Relapse After First Line Treatment (Cohort B),” presented at the 50th…
[cited by applicant]
Hillengass et al., 2024, “Phase 2 CARTITUDE-2 Update: Ciltacabtagene Autoleucel in Multiple Myeloma and 1-3 Prior Lines (Cohort A) and With Early Relapse After First Line Treatment (Cohort B),” presented by NWCJ van de …
[cited by applicant]
Hoda et al., 2021, “Considerations for Optimal Administration of Chimeric Antigen Receptor T-Cell Therapy Programs: A Multi-Stakeholder Qualitative Analysis,” presented at the 63rd American Society of Hematology (ASH) A…
[cited by applicant]
Hoda et al., 2022, “Considerations for Optimal Administration of Chimeric Antigen Receptor T-Cell Therapy Programs: A Multi-Stakeholder Qualitative Analysis,” presented at the 2022 Tandem Meetings - Transplantation & Ce…
[cited by applicant]
Iida et al., 2021, “The Result of CARTITUDE-1 Phase II Part of Cilta-cel in Relapsed/Refractory Multiple Myeloma Japanese Patients,” presented at the 83rd Annual Meeting of the Japanese Society of Hematology (JSH) Senda…
[cited by applicant]
Iida et al., 2022, “Efficacy and Safety of Cilta-cel in Relapsed/Refractory Multiple Myeloma Japanese Patients (CARTITUDE-1 Phase 2),” presented at the 84th Annual Meeting of the Japanese Society of Hematology, Oct. 14-…
[cited by applicant]
Jagannath et al., 2021, “Total Car-T Cost of Care Beyond the Price of Car-T Cell Therapy in Patients with Multiple Myeloma,” Blood, 138(Supplement 1):4964, Nov. 5, 2021, [retrieved on Jan. 12, 2022]. Retrieved from the …
[cited by applicant]
Jagannath et al., 2021, “Updated Results From Certitude-1: Ciltacabtageneautoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigenreceptor T (Car-T) Cell Therapy, in Relapsed/Refractory Multiple Myeloma (RRMM),”…
[cited by applicant]
Jagannath et al., 2022, “CAR-T Treatment Costs Beyond Therapy Acquisition Costs in Multiple Myeloma Patients,” poster EE70, May 2022 (1 page).
[cited by applicant]
Jagannath et al., 2022, “Healthcare Resource Utilization and Costs in Patients with Multiple Myeloma who Received 1 to 3 Prior Lines of Therapy, Including a Proteasome Inhibitor, an Immunomodulatory Drug, and Exposed to…
[cited by applicant]
Jagannath et al., 2023, “CARTITUDE-1 Final Results: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Heavily Pretreated Patients With Relapsed/Refractory Multiple Myeloma,” presented at the 20th International Myeloma So…
[cited by applicant]
Jakubowiak et al., 2021, “Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study,” presented at the 47th Annual Meeting…
[cited by applicant]
Jakubowiak et al., 2021, “CARTITUDE-1: Phase 1b/2 Study Of Ciltacabtagene Autoleucel (Cilta- Cel) In Relapsed/Refractory Multiple Myeloma (RRMM),” presented at The 7th World Congress on Controversies in Multiple Myeloma…
[cited by applicant]
Jakubowiak et al., 2021, “Incidence, Mitigation, and Management of Neurologic Adverse Events in the CARTITUDE-2 Study of Patients with Multiple Myeloma Treated with Ciltacabtagene Autoleuce (Cilta-Cel),” presented at So…
[cited by applicant]
Jakubowiak et al., 2021, “Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-Cel) in Patients With Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 Subgroup Analysis,” presented at the 63rd American Society of Hem…
[cited by applicant]
Kerre et al., 2022, “Ciltacabtagene Autoleucel (cilta-cel) B-cell Maturation Antigen (BCMA)—Directed Chimeric Antigen Receptor T Cell (CAR-T) Therapy in Patients With Early Relapse After Initial Multiple Myeloma (MM) Th…
[cited by applicant]
Lin et al., 2020, “Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE 1 Study,” presented at the 62nd American Society of H…
[cited by applicant]
Lin et al., 2021, “Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucel in the Phase 1b/2 CARTITUDE-1 Study,” presented at the Transplantation & Cellular…
[cited by applicant]
Lin et al., 2021, “Cytokine Release Syndrome (CRS) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With Ciltacabtagene Autoleucel (Cilta-Cel) in the Phase 1b/2 CARTITUDE-1 Study,” presented at The 7…
[cited by applicant]
Lin et al., 2022, “Meta-analysis of Ciltacabtagene Autoleucel versus Physician's Choice in the Treatment of Patients with Relapsed or Refractory MM (Encore),” presented at the 47th Annual Meeting of the Japanese Society…
[cited by applicant]
Lin et al., 2022, “Ciltacabtagene Autoleucel, a BCMA-Directed CAR-T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma: 2-Year Post LPI Results From the Phase 1b/2 CARTITUDE-1 Study,” presented at the E…
[cited by applicant]
Lin et al., 2023, “CARTITUDE-2 Final Results: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Heavily Pretreated Patients With Relapsed/Refractory Multiple Myeloma,” presented at the Annual Meeting of the American Soci…
[cited by applicant]
Madduri et al., 2020, “Update of CARTITUDE 1: A Phase 1b/2 Study of JNJ-68284528 (JNJ-4528), a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (Car-T) Cell Therapy, in Relapsed/Refractory Multiple …
[cited by applicant]
Madduri et al., 2020, “CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma,” presented at th…
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma,” presented at th…
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1B/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma (RRMM),” 2nd Meeting European Myeloma Network, Mar. 3- 6, 2021, Virtual (15 pages).
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma,” presented at th…
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1B/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma,” ICKSH 2021: Korean Society of Hematology International Conference & 62nd Annual Meeting, Apr. 1…
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma (RRMM),” presented at ESH 3rd How to Diagnose and Treat Multiple Myeloma, Apr. 15-18, 2021, Virtu…
[cited by applicant]
Madduri et al., 2021, “CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma,” presented at British Society for Haematology (BSH) 2021 Virtual Annual Scientific Meeting (ASM)…
[cited by applicant]
Mancia et al., 2022, “Clinical Strategies for Mitigation of Cytokine Release Syndrome and Neurotoxicity With Chimeric Antigen Receptor T Cell Therapy Ciltacabtagene Autoleucel in Multiple Myeloma,” presented at the Onco…
[cited by applicant]
Mancia et al., 2022, “Patient Identification for Chimeric Antigen Receptor T-Cell Therapy: Initial Insights From the CARTITUDE Program in Multiple Myeloma,” presented at the Oncology Nursing Society 2022 Congress, April…
[cited by applicant]
Manier et al., 2023, “EMagine/CARTITUDE-6: Randomized Phase 3 Study Comparing DVRd Followed by Ciltacabtagene Autoleucel Versus DVRd Followed by ASCT in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma…
[cited by applicant]
Manier et al., 2023, “Additional Analysis of CARTITUDE-4: Cilta-Cel vs Standard of Care (PVd or DPd) in Lenalidomide Refractory Patients With Multiple Myeloma and 1-3 Prior Lines of Therapy,” presented by S. Manier at t…
[cited by applicant]
Martin et al., 2020, “Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma,” poster P45 (1 page).
[cited by applicant]
Martin et al., 2020, “Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma,” presented at the 62nd American Society of Hematology (ASH) Annual Mee…
[cited by applicant]
Martin et al., 2021, “Cost per Responder Analysis to Assess the Value of CAR-T Therapy for Relapsed or Refractory Multiple Myeloma,” Blood, 138(Supplement 1):4961, Nov. 5, 2021, [retrieved on Jan. 3, 2022]. Retrieved fr…
[cited by applicant]
Martin et al., 2021, “Ciltacabtagene Autoleucel Versus Selinexor+ Dexamethasone in Triple-Class Exposed Patients With Relapsed/Refractory Multiple Myeloma: A Matching-Adjusted Indirect Comparison,” European Hematology A…
[cited by applicant]
Martin et al., 2021, “Health Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma,” presented at the 3rd European CAR-T Cell Meeting Virtual, Feb. 4-6, 2…
[cited by applicant]
Martin et al., 2021, “Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma,” presented at the Transplantation & Cellular Therapy (TCT) Meetings Di…
[cited by applicant]
Martin et al., 2021, “Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma,” presented at the 47th Annual Meeting of the EBMT, Mar. 14-17, 2021 (1…
[cited by applicant]
Martin et al., 2021, “Assessment of Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma,” presented at European School of Haematology (ESH) 3rd Ho…
[cited by applicant]
Martin et al., 2021, “Health-Related Quality of Life in the CARTITUDE-1 Study of Ciltacabtagene Autoleucel (Cilta-Cel) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM),” presented at The 7th World Congress o…
[cited by applicant]
Martin et al., 2021, “Comparison of Ciltacabtageneautoleucel (Cilta-cel) in CARTITUDE-1 vs Real- World Standard of Care for Patients With Triple-Class Exposed Relapsed/Refractory Multiple Myeloma,” presented at the Annu…
[cited by applicant]
Martin et al., 2021, “Updated Results From CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B cell Maturation Antigen Directed Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory …
[cited by applicant]
Martin et al., 2022, “Use of Cost per Responder Models for CAR-T Therapies in Relapsed or Refractory Multiple Myeloma,” poster EE167, May 2022 (1 page).
[cited by applicant]
Martin et al., 2022, “Ciltacabtagene Autoleucel (Cilta-cel), a B-cell Maturation Antigen-directed Chimeric Antigen Receptor T (Car-T) Cell Therapy, in Relapsed/Refractory Multiple Myeloma (Rrmm): CARTITUDE-1 Results 2 Y…
[cited by applicant]
Mateos et al., 2021, “LocoMMotion: A Prospective, Non-interventional, Multinational Study of Real- life Current Standards of Care in Patients With Relapsed/Refractory Multiple Myeloma Receiving 3 Prior Lines of Therapy,…
[cited by applicant]
Mateos et al., 2021, “A Prospective, Non-interventional, Multinational Study of Real-life Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma With >3 Prior Lines of Therapy: Interim Data from LocoMMot…
[cited by applicant]
Mateos et al., 2021, “Ciltacabtagene Autoleucel for Triple Class Exposed Multiple Myeloma: Adjusted Comparison of CARTITUDE-1 Outcomes Versus Real World Clinical Practice Observed from the LocoMMotion Prospective Study,…
[cited by applicant]
Mateos et al., 2022, “Treatment Comparison of Ciltacabtagene Autoleucel Versus Physician's Choice in Patients with Relapsed or Refractory Multiple Myeloma: A Meta Analysis,” presented at the 48th Annual Meeting of the E…
[cited by applicant]
Mateos et al., 2022, “Ciltacabtagene autoleucel (cilta-cel) versus real world clinical practice in triple- class exposed multiple myeloma: Adjusted comparison of patient reported outcomes from CARTITUDE-1 and LocoMMotio…
[cited by applicant]
Mateos et al., 2023, “Cilta-cel Efficacy And Safety In Patients With Progressive Multiple Myeloma After Noncellular Anti-BCMA Immunotherapy,” presented at the 49th European Society for Blood and Marrow Transplantation (…
[cited by applicant]
Mateos et al., 2023, “Adjusted Comparisons of CiltacabtageneAutoleucelWith Therapies From Real- World Clinical Practice: Two-Year Follow-Up Analyses From CARTITUDE-1 and the Prospective LocoMMotion Study,” presented at …
[cited by applicant]
Mehra et al., 2020, “Patient Characteristics, Treatment Patterns, and Outcomes in Patients With Triple- Class-Refractory Multiple Myeloma,” presented at the 25th European Hematology Association (EHA) Annual Congress, Ju…
[cited by applicant]
Mi et al., 2022, “Phase 2, Open-label Study of Ciltacabtagene Autoleucel, an Anti-BCMA CAR-T Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1): 26-month Median Follow-up,” presente…
[cited by applicant]
Mi et al., 2023, “Phase 2 Study of Ciltacabtagene Autoleucel in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1): 26 Month Median Follow up (Encore),” presented at the 48th Japanese Society of Mye…
[cited by applicant]
Mi et al., 2023, “Long-Term Remission and Survival in Patients With Relapsed or Refractory Multiple Myeloma After Treatment With LCAR-B38M Car-T: >5-Year Follow-Up in LEGEND-2,” presented at the Annual Meeting of the Am…
[cited by applicant]
Mi et al., 2023, “Long-Term Remission and Survival in Patients With Relapsed or Refractory Multiple Myeloma After Treatment With LCAR-B38M Car-T: >5-Year Follow-Up in LEGEND-2,” presented at the European Hematology Asso…
[cited by applicant]
Mina et al., 2023, “Patient-Reported Outcomes in the Phase 3 CARTITUDE-4 Study of Ciltacabtagene Autoleucel vs Standard of Care in Patients With Lenalidomide-Refractory Multiple Myeloma After 1-3 Lines of Therapy,” pres…
[cited by applicant]
Mina et al., 2024, “Patient Reported Outcomes CARTITUDE-4 Study (Phase 3) of Ciltacabtagene Autoleucel vs Standard of Care in Patients with Lenalidomide Refractory Multiple Myeloma After 1-3 Lines of Therapy,” presented…
[cited by applicant]
Mina et al., 2024, “CARTITUDE-4 Study (Phase 3) Patient-Reported Outcomes of Ciltacabtagene Autoleucel vs Standard of Care in Patients With Lenalidomide-Refractory Multiple Myeloma After 1-3 Lines of Therapy,” Presented…
[cited by applicant]
Moreau et al., 2021, “LocoMMotion: A Prospective, Non-interventional, Multinational Study of Real- life Current Standards of Care in Patients With Relapsed/Refractory Multiple Myeloma Who Received 3 Prior Lines of Thera…
[cited by applicant]
Moreau et al., 2022, “Characterization and outcomes of spanish patients with relapsed/refractory multiple myeloma (RRMM) receiving 3 prior lines of therapy included in the prospective locommotion study,” poster (1 page).
[cited by applicant]
Moreau et al., 2022, “Adjusted Comparison of Patient Reported Outcomes From CARTITUDE-1 and LocoMMotion Comparing Ciltacabtagene Autoleucel Versus Real World Clinical Practice in Triple-Class Exposed Multiple Myeloma,” …
[cited by applicant]
Moreau et al., 2022, “Adjusted Comparisons of Outcomes in Patients with Triple class exposed Multiple Myeloma: Ciltacabtagene Autoleucel (Cilta-Cel) from the CARTITUDE-1 Study Compared with Therapies in Real-world Clini…
[cited by applicant]
Moreau et al., 2022, “Ciltacabtagene Autoleucel versus Physician's Choice in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma: Results from Meta-analyses,” presented at the French Society of Hemato…
[cited by applicant]
Moreau et al., 2022, “Updated Results From LocoMMotion: A Prospective, Noninterventional, Multinational Study of Real-life Current Standards of Care in Heavily Pretreated Patients With Relapsed/Refractory Multiple Myelo…
[cited by applicant]
Moreau et al., 2023, “LocoMMotion: A Prospective, Observational, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed/Refractory Multiple Myeloma-Final Analysis at 2- Year Follow-Up,” pre…
[cited by applicant]
Moreau et al., 2024, “LocoMMotion: A Prospective, Observational, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed/Refractory Multiple Myeloma - Final Analysis at 2-Year Follow-Up,” pr…
[cited by applicant]
Moreau et al., 2024, “LocoMMotion: A Prospective, Observational, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed/Refractory Multiple Myeloma - Final Analysis at 2-Year Follow-Up,” pr…
[cited by applicant]
Munshi et al., 2022, “Efficacy Outcomes and Characteristics of Patients With Multiple Myeloma Who Achieved Sustained Minimal Residual Disease Negativity After Treatment With Ciltacabtagene Autoleucel in CARTITUDE-1,” pr…
[cited by applicant]
Munshi et al., 2023, “CARTITUDE 1 Final Results: Phase 1b/2 Study of Ciltacabtagene Autoleucel in Heavily Pretreated Patients With Relapsed/Refractory Multiple Myeloma, ” presented at the European Hematology Association…
[cited by applicant]
Perrot et al., 2022, “Real life Standard of care Therapies for Patients With Relapsed/Refractory Multiple Myeloma Who Received >3 Prior Lines of Therapy: The Prospective, Non interventional, Multinational LocoMMotion St…
[cited by applicant]
Perrot et al., 2022, “Real life Standard of care Therapies for Patients With Relapsed/Refractory Multiple Myeloma Who Received >3 Prior Lines of Therapy: The Prospective, Non interventional, Multinational LocoMMotion St…
[cited by applicant]
Raghunandan et al., 2022, “Bcma Car-T after Allogeneic HCT Induces Remission in Refractory Plasmablastic Lymphoma,” Children's Healthcare of Atlanta Inc., poster (1 page).
[cited by applicant]
Rodriguez-Otero, et al., 2023, “Cilta-Cel Efficacy and Safety in Patients With Progressive Multiple Myeloma After Noncellular Anti-BCMA Immunotherapy,” presented at The 9th World Congress on Controversies in Multiple My…
[cited by applicant]
Sidiqi et al., 2023, “Efficacy and Safety in Patients With Lenalidomide-Refractory Multiple Myeloma and 1-3 Prior Lines Who Received a Single Infusion of Ciltacabtagene Autoleucel as Study Treatment in the Phase 3 CARTI…
[cited by applicant]
Sidiqi et al., 2024, “Efficacy and Safety in Patients With Lenalidomide-Refractory Multiple Myeloma and 1-3 Prior Lines Who Received Ciltacabtagene Autoleucel as Study Treatment CARTITUDE-4 Trial (Phase 3),” presented a…
[cited by applicant]
Sidiqi et al., 2024, “Efficacy and Safety in Patients With Lenalidomide-Refractory Multiple Myeloma and 1-3 Prior Lines Who Received Ciltacabtagene Autoleucel As Study Treatment CARTITUDE-4 Trial (Phase 3),” presented b…
[cited by applicant]
Singh et al., 2020, “Preliminary Clinical Pharmacokinetic Analysis of CARTITUDE-1, a Phase 1b/2 Study of JNJ-4528 (Bcma Car-T) Cell Therapy in Patients with Relapsed and/or Refractory Multiple Myeloma,” presented at 202…
[cited by applicant]
Sonneveld et al., 2023, “DVRd Followed by Ciltacabtagene Autoleucel Versus DVRd Followed by ASCT in Patients With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible: A Randomized Phase 3 Study (EMagine/CARTITU…
[cited by applicant]
Sonneveld, et al., 2023, “Ciltacabtagene Autoleucel (Cilt- Cel), a BCMA-Directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy: CARTITUDE-2 Cohort B 18-Month Follow-U…
[cited by applicant]
Suvannasankha et al., 2023, “Cilta-Cel Efficacy and Safety in Patients with Progressive Multiple Myeloma after Exposure to Non-cellular Anti-BCMA Immunotherapy,” presented at the 2023 Tandem Meetings Transplantation & C…
[cited by applicant]
Sweiss et al., 2022, “Effect of Predicted Fludarabine Lymphodepletion Exposure on Clinical Outcomes in Myeloma Patients Undergoing BCMA-CAR-T: An Exploratory Analysis from CARTITUDE-1,” presented at the 64th American So…
[cited by applicant]
Sweiss et al., 2023, “An Exploratory Analysis on the Effect of Predicted Fludarabine Lymphodepletion Exposure on Clinical Outcomes in Patients with Relapsed and Refractory Multiple Myeloma (RRMM) Who Received BCMA CAR-T…
[cited by applicant]
Usmani et al., 2021, “Updated Results of Ciltacabtagene Autoleucel (Cilta-Cel), a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (Car-T) Cell Therapy, in Relapsed/Refractory Multiple Myeloma (RRMM…
[cited by applicant]
Usmani et al., 2021, “Ciltacabtagene Autoleucel , A B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T-Cell (CAR-T) Therapy, In Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results From CART…
[cited by applicant]
Usmani et al., 2021, “Cytokine Release Syndrome in Patients With Relapsed/Refractory Multiple Myeloma Treated With Ciltacabtagene Autoleucelin the Phase 1b/2 CARTITUDE-1 Study,” presented at the 3rd European CAR T-Cell …
[cited by applicant]
Usmani et al., 2021, “Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T-Cell (CAR-T) Therapy, in Relapsed/Refractory Multiple Myeloma (R/R Mm): Updated Results From CARTI…
[cited by applicant]
Usmani et al., 2021, “Updated CARTITUDE-1 Results of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma,” presented at the A…
[cited by applicant]
Usmani et al., 2021, “Updated results of ciltacabtagene autoleucel (Cilta-Cel),a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T (CAR-T) cell therapy, in relapsed/refractory multiple myeloma (RRMM)…
[cited by applicant]
Usmani et al., 2021, “Updated Results of Ciltacabtagene Autoleucel (Cilta-Cel), a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (CAR-T) Cell Therapy, in Relapsed/Refractory Multiple Myeloma (RRMM…
[cited by applicant]
Usmani et al., 2021, “Updated Results From the CARTITUDE-1 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma,” pre…
[cited by applicant]
Usmani et al., 2022, “Ciltacabtagene Autoleucel Efficacy and Safety in Patients With Rrmm: CARTITUDE-1 Subgroup Analysis,” presented at the 44th Annual Meeting of the Japanese Society for Transplantation and Cellular Th…
[cited by applicant]
Usmani et al., 2022, “Ciltacabtagene Autoleucel Efficacy and Safety in Patients With Rrmm: CARTITUDE-1 Subgroup Analysis (Encore),” presented at the 47th Annual Meeting of the Japanese Society of Melanoma (JSM), May 20-…
[cited by applicant]
Usmani et al., 2022, “Phase 1b/2 Study of Ciltacabtagene Autoleucel, a BCMA-Directed CAR-T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma (CARTITUDE-1): 2 Years Post LPI,” presented at the 2022 Amer…
[cited by applicant]
Usmani et al., 2022, “CARTITUDE-1: Two-year Post Last Patient In (LPI) Results from the Phase 1b/2 Study of CiltacabtageneAutoleucel(Cilta-cel), a B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T (C…
[cited by applicant]
Usmani et al., 2022, “CARTITUDE 1-2 Year Update: Cilta-cel Efficacy and Safety in Patients With Relapsed/Refractory Multiple Myeloma,” presented at the 84th Annual Meeting of the Japanese Society of Hematology, Oct. 14-…
[cited by applicant]
Usmani et al., 2023, “Characteristics of Patients With Sustained Minimal Residual Disease Negativity in CARTITUDE-1,” presented at the 45th Annual Meeting of the Japanese Society for Transplantation and Cellular Therapy…
[cited by applicant]
Van De Donk et al., 2021, “Incidence, Mitigation, and Management of Neurologic Adverse Events in the CARTITUDE-2 Study of Ciltacabtagene Autoleucel,” presented at European School of Haematology (ESH) (5 pages).
[cited by applicant]
Van De Donk et al., 2021, “CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Autoleucel, a B- cell Maturation Antigen-Directed Chimeric Antigen Receptor T cell Therapy, in Patients With Multiple Myeloma and Early Relap…
[cited by applicant]
Van De Donk et al., 2022, “CARTITUDE- 2 Cohort B: Efficacy and Safety of Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T-Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients With Multiple Myelom…
[cited by applicant]
Van De Donk et al., 2022, “Safety and Efficacy of Ciltacabtagene Autoleucel, aChimeric Antigen Receptor T-Cell Therapy Directed Against B-Cell Maturation Antigen in Patients with Multiple Myeloma and Early Relapse After…
[cited by applicant]
Van De Donk et al., 2022, “Ciltacabtagene Autoleucel (Cilta-Cel), a B-Cell Maturation Antigen (BCMA) Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients (PTS) with Multiple Myeloma (MM) and Early Relaps…
[cited by applicant]
Van De Donk et al., 2022, “Cilta-cel, a BCMA Directed CAR-T, in MM Patients with Early Relapse After Initial Therapy (CARTITUDE-2),” presented at the 44th Annual Meeting of the Japanese Society for Transplantation and C…
[cited by applicant]
Van De Donk et al., 2022, “Biological Correlative Analyses and Updated Clinical Data of Ciltacabtagene Autoleucel, a BCMA-Directed CAR-T Cell Therapy, in Patients With Multiple Myeloma and Early Relapse After Initial Th…
[cited by applicant]
Van De Donk et al., 2022, “Ciltacabtagene Autoleucel (Cilta-Cel), a BCMA-directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy: CARTITUDE-2 Cohort B 18-Month Follow-…
[cited by applicant]
Van De Donk et al., 2023, “Cilta-cel Efficacy and Safety in Anti-BCMA Exposed Multiple Myeloma Patients: CARTITUDE-2 Cohort C,” presented at the 45th Annual Meeting of the Japanese Society for Transplantation and Cellul…
[cited by applicant]
Van De Donk et al., 2023, “Efficacy and Safety of Cilta-cel in Patients With Progressive Multiple Myeloma After Exposure to Non-cellular Anti-BCMA Immunotherapy,” presented at the 4th European Myeloma Network (EMN) Annu…
[cited by applicant]
Van De Donk et al., 2023, “CARTITUDE-2 Cohort B 18-Month Follow-up: Ciltacabtagene Autoleucel Cilta-cel), a BCMA-directed CAR T-Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therap…
[cited by applicant]
Van De Donk et al., 2023, “Ciltacabtagene Autoleucel in Patients With Multiple Myeloma With Early Relapse After Initial Therapy: CARTITUDE 2 Cohort B 18 Month Follow up (Encore),” presented at the 48th Japanese Society …
[cited by applicant]
Vekemans et al., 2022, “Ciltacabtagene Autoleucel for Patients With Triple-Class Exposed Multiple Myeloma: Adjusted Comparison of CARTITUDE-1 Patient Outcomes Versus Real-world Clinical Practice in Belgium,” presented a…
[cited by applicant]
Vekemans et al., 2022, “Treatments in Patients with Relapsed/Refractory Multiple Myeloma: Retrospective Chart Review of Real World Outcomes for Standard of Care,” presented at the 3rd European Myeloma Network Meeting, A…
[cited by applicant]
Vekemans et al., 2022, “Real-World Outcomes (RWO) for Standard of Care (SOC) Treatments in Patients with Relapsed or Refractory Multiple Myeloma (RRMM),” The 8th World Congress on Controversies in Multiple Myeloma (COMy…
[cited by applicant]
Weisel et al., 2021, “Characteristics and Treatment Patterns of Triple-Class Exposed Patients With Relapsed/Refractory Multiple Myeloma Who Participated in Clinical Trials of Daratumumab,” presented at the 47th Annual M…
[cited by applicant]
Weisel et al., 2021, “Comparison of Ciltacabtagene Autoleucel (Cilta-cel) in CARTITUDE-1 Versus Standard of Care in Triple-Class Exposed Multiple Myeloma Patients in Clinical Trials of Daratumumab,” European Hematology …
[cited by applicant]
Weisel et al., 2021, “Matching-Adjusted Indirect Comparison of Ciltacabtagene Autoleucel Versus Belantamab Mafodotin in Patients With Triple-Class Exposed Relapsed/Refractory Multiple Myeloma,” European Hematology Assoc…
[cited by applicant]
Weisel et al., 2022, “Updated Results of Ciltacabtagene Autoleucel (Cilta-cel), Chimeric Antigen Receptor T Cell (CAR-T) Therapy in Lenalidomide Refractory Multiple Myeloma (MM) After 1-3 Prior Lines of Therapy,” presen…
[cited by applicant]
Weisel et al., 2022, “Ciltacabtagene Autoleucel (Cilta-Cel) Versus Physician's Choice of Treatment (PCT): A Meta Analysis in Patients with Relapsed or Refractory Multiple Myeloma (RRMM),” presented at the 8th World Cong…
[cited by applicant]
Weisel et al., 2022, “Adjusted Comparison of Patient Reported Outcomes From CARTITUDE-1 and LocoMMotion Comparing Ciltacabtagene Autoleucel Versus Real World Clinical Practice in Triple-Class Exposed Multiple Myeloma,” …
[cited by applicant]
Weisel et al., 2022, “Ciltacabtagene Autoleucel (Cilta-cel) vs Real-world Clinical Practice (RWCP) in Triple-class Exposed Multiple Myeloma (TCEMM): Adjusted Comparison of Patient-reported Outcomes (PROs) From CARTITUDE…
[cited by applicant]
Weisel et al., 2023, “LocoMMotion: A Prospective, Observational, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed/RefractoryMultiple Myeloma - Final Analysis at 2- Year Follow-Up,” pr…
[cited by applicant]
Wong et al., 2021, “Anakinra Targeting Cytokine Release Syndrome Associated With Chimeric Antigen Receptor T-cell Therapies,” presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. …
[cited by applicant]
Wong et al., 2022, “Anakinra Targeting Cytokine Release Syndrome (CRS) Associated With Chimeric Antigen Receptor T cell (CAR-T) Therapies,” presented at the 2022 Tandem Meetings Transplantation & Cellular Therapy Meetin…
[cited by applicant]
Wu et al., 2022, “Population Pharmacokinetic Modeling of Ciltacabtagene autoleucel in Subjects with Relapsed or Refractory Multiple Myeloma,” presented at the American Association for Cancer Research (AACR) Annual Meeti…
[cited by applicant]
Wu et al., 2022, “CAR-T Cell Therapy PopPK and E-R Using Ciltacabtagene Autoleucel as Example,” presented at the American Conference on Pharmacometrics, Oct. 30 to Nov. 2, 2022, Aurora, CO (17 pages).
[cited by applicant]
Yong et al., 2023, “Daratumumab Clinical Trial Analysis: Outcomes in Patients With Lenalidomide- Refractory Relapsed/Refractory Multiple Myeloma, 1-3 Prior Lines of Therapy,” presented at the 2023 British Society for Ha…
[cited by applicant]
Zweegman et al., 2023, “CARTITUDE-2 Cohort B 18-Month Follow-up: Ciltacabtagene Autoleucel Cilta-cel), a BCMA-directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy,”…
[cited by applicant]
Berdeja et al., 2021, “Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-l…
[cited by applicant]
Jagannath et al., 2025, “Long-Term (>5-Year) Remission and Survival After Treatment With Ciltacabtagene Autoleucel in CARTITUDE-1 Patients With Relapsed/Refractory Multiple Myeloma,” J. Clin. Oncol., JCO2500760 (8 pages…
[cited by applicant]
Berdeja et al., 2020, “Update of CARTITUDE-1: A phase Ib/II study of JNJ-4528, a B-cell maturation antigen (BCMA)-directed CAR-T-cell therapy, in relapsed/refractory multiple myeloma,” 2020 ASCO Annual Meeting I, May 25…
[cited by applicant]
Fan et al., 2017, “Durable remissions with BCMA-specific chimeric antigen receptor (CAR)-modified T cells in patients with refractory/relapsed multiple myeloma,” J. Clin. Oncol. 35(Supplement_18):LBA3001 (2 pages).
[cited by applicant]
Madduri et al., 2019, “Results from CARTITUDE-1: A Phase 1b/2 Study of JNJ-4528, a CAR-T Cell Therapy Directed Against B-Cell Maturation Antigen (BCMA), in Patients with Relapsed and/or Refractory Multiple Myeloma (R/R …
[cited by applicant]
Zudaire et al., 2019, “Translational Analysis from CARTITUDE-1, an Ongoing Phase 1b/2 Study of JNJ-4528 BCMA-targeted CAR-T Cell Therapy in Relapsed and/or Refractory Multiple Myeloma (R/R MM), Indicates Preferential Ex…
[cited by applicant]
ClinicalTrial NCT03548207 (v5), “A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma,” first …
[cited by applicant]
ClinicalTrial NCT03548207 (v17), “A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma,” first…
[cited by applicant]
ClinicalTrial NCT03548207 (v23), “A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma,” first…
[cited by applicant]
Madduri et al., 2020, “Phase 1b results from CARTITUDE-1: A phase 1b/2 study of JNJ-4528, a chimeric antigen receptor T (CAR-T) cell therapy directed against B-cell maturation antigen (BCMA), in patients with relapsed a…
[cited by applicant]
Blaeschke et al., 2018, “Induction of a central memory and stem cell memory phenotype in functionally active CD4+ and CD8+ CAR T cells produced in an automated good manufacturing practice system for the treatment of CD1…
[cited by applicant]
Sommermeyer et al., 2016, “Chimeric antigen receptor-modified T cells derived from defined CD8+ and CD4+ subsets confer superior antitumor reactivity in vivo,” Leukemia, 30(2):492-500 (Epub 2015).
[cited by applicant]