Granted Patent
B2
US 12,600,775 · App. 17/091,039 · Granted Apr 14, 2026
Chimeric antigen receptor T cell therapy
Assignee:
Kite Pharma, Inc.
C07K16/2803A61K9/0019A61K31/675A61K31/7076A61K38/1774A61K39/3955A61K40/11A61K40/31A61K40/4211A61P35/00A61P35/02C07K14/7051C07K14/70521C12N5/0636G01N33/505G01N33/57426A61K2039/545A61K2239/38A61K2239/48C07K2317/622C07K2317/76C07K2319/30C07K2319/33C12N2501/505C12N2506/11
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Abstract
Provided herein are methods for preparing, producing, processing, culturing, isolating, or making cells suitable for immune or cell therapy, and for their use in cell therapy.
Claims (9)
1 . A method for treating relapsed or refractory mantle cell lymphoma (MCL) in a subject in need thereof that has a Ki-67 tumor proliferation index ≥50% or presence of a TP53 mutation, comprising administering to the subject a therapeutically effective amount of a composition which comprises autologous T cells expressing an anti-CD19 chimeric antigen receptor (CAR) wherein the T cells comprise CD4+ and CD8+ CAR T cells that are prepared from peripheral blood mononuclear cells (PBMCs) by positive enrichment and partial or complete depletion of circulating cancer cells and wherein the anti-CD19 CAR comprises an anti-CD19 single-chain variable fragment (scFv) comprising the heavy chain and light chain variable regions of FMC63, a CD28 intracellular signaling region, and a CD3-zeta signaling domain.
2 . The method of claim 1 , wherein the MCL is refractory to, or has relapsed following, one or more of chemotherapy, radiotherapy, immunotherapy, an autologous stem cell transplant, or any combination thereof.
3 . The method of claim 1 , wherein the subject has received 1-5 prior treatments, optionally wherein at least one of the prior treatments is selected from autologous SCT, anti-CD20 antibody, anthracycline- or bendamustine-containing chemotherapy, and/or a Bruton Tyrosine Kinase inhibitor (BTKi).
4 . The method of claim 3 , wherein the BTKi is ibrutinib or acalabrutinib.
5 . The method of claim 1 , wherein the subject receives a bridging therapy after leukapheresis to obtain the PBMCs and before the consequent partial or complete depletion of circulating cancer cells.
6 . The method of claim 5 , wherein the bridging therapy is selected from dexamethasone, ibrutinib, and/or acalabrutinib.
7 . The method of claim 1 , wherein the subject receives a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously, both given on each of the fifth, fourth, and third days before T cell infusion.
8 . The method of claim 1 , wherein the PBMC are enriched for T cells by selection for CD4+ and CD8+ cells, activated with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, and then transduced with a replication-incompetent viral vector containing a polynucleotide encoding the anti-CD19 CAR.
9 . The method of claim 1 , wherein the subject is administered a dose of 1×10 6 to 2×10 6 CAR positive viable T cells per kg body weight, with a maximum of 2×10 8 CAR positive viable T cells.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 14, 2021
From: BOT, ADRIAN I.; ROSSI, JOHN M.
To: KITE PHARMA, INC.
Reel/Frame 054925/0544 →
Continuity (7)
Provisional Application
63089930
· Oct 9, 2020
Provisional Application
63063692
· Aug 10, 2020
Provisional Application
63056369
· Jul 24, 2020
Provisional Application
63031217
· May 28, 2020
Provisional Application
62944937
· Dec 6, 2019
Provisional Application
62931636
· Nov 6, 2019
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