IP Library › Granted Patent US 12,076,344
Granted Patent B2
US 12,076,344 · App. 17/296,859 · Granted Sep 3, 2024

T-Rapa cells as novel effector cell type for chimeric antigen receptor therapy

Inventors: Jeffrey A. Medin (Shorewood, WI); Robyn A. Oldham (Milwaukee, WI); Daniel H. Fowler (Bethesda, MD); Tania Felizardo (Charlottesville, VA)
Assignees: The Medical College of Wisconsin, Inc.; University of Virginia Patent Foundation
A61K35/17C12N5/0636C12N2501/04C12N2501/2302C12N2501/24C12N2510/00
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Quick Facts
Patent No.
US 12,076,344
App. No.
17/296,859
Granted
Sep 3, 2024
Kind
B2
Abstract

The present disclosure provides chimeric antigen receptor (CAR)-T-Rapa cells and methods of making and using them. Specifically, methods of producing T-Rapa cells that can express chimeric antigen receptors is provided.

Claims (26)

1. A method of making a T- Rapa cell expressing a chimeric antigen receptor (CAR) comprising the steps of:

(a) conditioning ex vivo CD3+T-cells with rapamycin to generate T-cells resistant to rapamycin (T- Rapa cells); and

(b) transducing the T- Rapa cells in vitro with a vector that expresses the CAR to produce CAR-T- Rapa cells.

2. A CAR-T- Rapa cell comprising:

an exogenous vector encoding and capable of expressing a chimeric antigen receptor (CAR), wherein the T- Rapa cells are made by culturing ex vivo CD3+T-cells in chemically defined medium comprising rapamycin for sufficient time to generate T-cells resistant to rapamycin (T- Rapa cells).

3. The CAR-T- Rapa cell of claim 2 , wherein the T cells are obtained from a subject or suitable donor.

4. The CAR T- Rapa cell of claim 2 , wherein the vector is a viral vector.

5. The CAR T- Rapa cell of claim 2 , wherein the T cells are obtained from the subject or suitable donor by

(i) obtaining a sample from the subject; and

(ii) detecting and isolating CD3+T-cells from the sample and culturing the isolated T-cells in vitro.

6. The CAR T- Rapa cell of claim 2 , wherein the vector is a lentiviral vector.

7. The CAR T- Rapa cell of claim 2 , wherein the chemically defined medium comprises about 0.1 to about 2 micromolar rampamycin.

8. The CAR T- Rapa cells of claim 7 , wherein the chemically defined medium comprises IL-2 and IFN-α.

9. The CAR T- Rapa cell of claim 2 , wherein the CAR is a CAR specific to a tumor antigen.

10. The CAR T- Rapa cell of claim 2 , wherein the CAR is a CD19 CAR.

11. A method of treating a subject diagnosed with a disease that is treatable with CAR therapy, the method comprising:

administering an effective amount of the CAR-T- Rapa cell of claim 2 to treat the subject.

12. The method of claim 11 , wherein the disease is cancer.

13. The method of claim 12 , wherein the cancer is a hematologic cancer.

14. The method of claim 12 , wherein the cancer is a solid tumor.

15. The method of claim 11 , wherein the CAR-T- Rapa cells are introduced by intravenous transfusion.

16. A population comprising the CAR T- Rapa cells of claim 2 , wherein at least 95% of the T Rapa cells express one or more biomarkers indicative of CAR expression.

17. The population of claim 16 , wherein the population is capable of maintaining and expanding in_in vitro culture.

18. A stored population of CAR T Rapa cells, comprising the population of claim 17 , a storage solution, and wherein the population is stored at or below about −80° C. in suitable storage solution until used.

19. A CAR-T- Rapa cell comprising:

an exogenous vector encoding and capable of expressing a chimeric antigen receptor (CAR), wherein the CAR-T- Rapa cell is resistant to rapamycin.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2024
From: FELIZARDO, TANIA
To: UNIVERSITY OF VIRGINIA
Reel/Frame 068125/0340 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2024
From: UNIVERSITY OF VIRGINIA
To: UNIVERSITY OF VIRGINIA PATENT FOUNDATION
Reel/Frame 068125/0499 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2021
From: MEDIN, JEFFREY A.; OLDHAM, ROBYN A.A.
To: THE MEDICAL COLLEGE OF WISCONSIN, INC.
Reel/Frame 056910/0407 →
Continuity (2)
Provisional Application 62773339 · Nov 30, 2018
Related Publication 20220016167A1 · Jan 20, 2022