IP Library Granted Patent US 9,101,584
Granted Patent B2
US 9,101,584 · App. 14/568,195 · Granted Aug 11, 2015

Methods for treatment of cancer

Inventors: Carl H. June (Merion Station, PA); Bruce L. Levine (Cherry Hill, NJ); David L. Porter (Springfield, PA); Michael D. Kalos (Philadelphia, PA); Michael C. Milone (Cherry Hill, NJ)
Assignee: The Trustees of the University of Pennsylvania
A61K35/17
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Quick Facts
Patent No.
US 9,101,584
App. No.
14/568,195
Granted
Aug 11, 2015
Kind
B2
Abstract

The present invention provides compositions and methods for treating cancer in a human. The invention includes relates to administering a genetically modified T cell to express a CAR wherein the CAR comprises an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 zeta signaling domain.

Claims (30)

1. A method of treating a hematological cancer in a human patient, the method comprising administering to the human patient a pharmaceutical composition comprising an antitumor effective amount of a population of human T cells, wherein the cells of the population include cells that comprise a nucleic acid sequence that encodes a chimeric antigen receptor (CAR), wherein the CAR comprises a CD19 antigen binding domain comprising the amino acid sequence of SEQ ID NO: 20, a CD8α hinge domain, a CD8α transmembrane domain, a 4-1BB costimulatory signaling region, and a CD3 zeta signaling domain, wherein the T cells are T cells of a human patient having a hematological cancer.

2. The method of claim 1 , wherein the anti-tumor effective amount of T cells is 10 4 to 10 9 cells per kg body weight of the human patient.

3. The method of claim 1 , wherein the anti-tumor effective amount of T cells is 10 5 to 10 6 cells per kg body weight of the human patient.

4. The method of claim 1 , wherein the CD8α transmembrane domain comprises the amino acid sequence of SEQ ID NO: 22.

5. The method of claim 1 , wherein the CD8α hinge domain comprises the amino acid sequence of SEQ ID NO: 21.

6. The method of claim 1 , wherein the 4-1BB costimulatory signaling region comprises the amino acid sequence of SEQ ID NO: 23.

7. The method of claim 1 , wherein the CD3 zeta signaling domain comprises the amino acid sequence of SEQ ID NO: 24.

8. The method of claim 1 , wherein the CD19 binding domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 14.

9. The method of claim 4 , wherein the CD8α transmembrane domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 16.

10. The method of claim 5 , wherein the CD8α hinge domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 15.

11. The method of claim 6 , wherein the 4-1BB costimulatory signaling region is encoded by a nucleic acid sequence comprising SEQ ID NO: 17.

12. The method of claim 7 , wherein the CD3 zeta signaling domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 18.

13. The method of claim 1 , wherein the hematological cancer is leukemia.

14. The method of claim 13 , wherein the leukemia is chronic lymphocytic leukemia (CLL) or acute lymphocytic leukemia (ALL).

15. The method of claim 1 , wherein the hematological cancer is lymphoma.

16. The method of claim 15 , wherein the lymphoma is non-Hodgkin's lymphoma, Hodgkin's lymphoma or mantle cell lymphoma.

17. The method of claim 1 , wherein the hematological cancer is multiple myeloma.

18. The method of claim 4 , wherein the CD8α hinge domain comprises the amino acid sequence of SEQ ID NO: 21.

19. The method of claim 18 , wherein the CD8α hinge domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 15.

20. The method of claim 6 , wherein the CD8α hinge domain comprises the amino acid sequence of SEQ ID NO: 21.

21. The method of claim 20 , wherein the CD8α hinge domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 15.

22. The method of claim 7 , wherein the CD8α hinge domain comprises the amino acid sequence of SEQ ID NO: 21.

23. The method of claim 22 , wherein the CD8α hinge domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 15.

24. The method of claim 6 , wherein the CD8α transmembrane domain comprises the amino acid sequence of SEQ ID NO: 22.

25. The method of claim 24 , wherein the CD8α transmembrane domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 16.

26. The method of claim 7 , wherein the CD8α transmembrane domain comprises the amino acid sequence of SEQ ID NO: 22.

27. The method of claim 26 , wherein the CD8α transmembrane domain is encoded by a nucleic acid sequence comprising SEQ ID NO: 16.

28. A method of treating lymphoma in a human patient, the method comprising administering to the human patient a pharmaceutical composition comprising an antitumor effective amount of a population of human T cells, wherein the cells of the population include cells that comprise a nucleic acid sequence that encodes a chimeric antigen receptor (CAR), wherein the CAR comprises a CD19 antigen binding domain comprising the amino acid sequence of SEQ ID NO:20, a CD8α hinge domain comprising the amino acid sequence of SEQ ID NO:21, a CD8α transmembrane domain comprising the amino acid sequence of SEQ ID NO:22, a 4-1 BB costimulatory signaling region comprising the amino acid sequence of SEQ ID NO:23, and a CD3 zeta signaling domain comprising the amino acid sequence of SEQ ID NO:24, wherein the T cells are T cells of a human patient having lymphoma.

29. The method of claim 28 , wherein the lymphoma is non-Hodgkin's lymphoma, Hodgkin's lymphoma or mantle cell lymphoma.

30. A method of treating multiple myeloma in a human patient, the method comprising administering to the human patient a pharmaceutical composition comprising an antitumor effective amount of a population of human T cells, wherein the cells of the population include cells that comprise a nucleic acid sequence that encodes a chimeric antigen receptor (CAR), wherein the CAR comprises a CD19 antigen binding domain comprising the amino acid sequence of SEQ ID NO:20, a CD8α hinge domain comprising the amino acid sequence of SEQ ID NO:21, a CD8α transmembrane domain comprising the amino acid sequence of SEQ ID NO:22, a 4-1 BB costimulatory signaling region comprising the amino acid sequence of SEQ ID NO:23, and a CD3 zeta signaling domain comprising the amino acid sequence of SEQ ID NO:24, wherein the T cells are T cells of a human patient having multiple myeloma.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 3, 2024
From: JUNE, CARL H.; LEVINE, BRUCE L.; PORTER, DAVID L.; KALOS, MICHAEL D.; MILONE, MICHAEL C.
To: THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
Reel/Frame 067599/0455 →
CONFIRMATORY LICENSE Recorded Jan 28, 2019
From: UNIVERSITY OF PENNSYLVANIA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 048151/0491 →
Continuity (4)
Continuation 13992622
Provisional Application 61421470 · Dec 9, 2010
Provisional Application 61502649 · Jun 29, 2011
Related Publication 20150118202A1 · Apr 30, 2015