IP Library Granted Patent US 10,563,172
Granted Patent B2
US 10,563,172 · App. 15/458,339 · Granted Feb 18, 2020

Methods of T cell expansion and activation

Inventors: Peiman Hematti (Middleton, WI); Debra Bloom (Sun Prairie, WI)
Assignee: Wisconsin Alumni Research Foundation
C12N5/0638A61K9/0019A61K35/17A61K39/0011A61K2039/5158C12N2501/50C12N2501/515C12N2501/599C12N2510/00
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Quick Facts
Patent No.
US 10,563,172
App. No.
15/458,339
Granted
Feb 18, 2020
Kind
B2
Abstract

The present disclosure relates to methods, cells, and compositions for preparing T cell populations and compositions for adoptive cell therapy. In particular, provided herein are methods for efficiently expanding and activating T cell populations for genetic engineering and adoptive T cell immunotherapies. Also provided are cells and compositions produced by the methods and methods of their use.

Claims (47)

1. A method of preparing a population of T cells, the method comprising

(a) reducing BAFF-R receptor activity in the T cells; and

(b) culturing the T cells of (a) for about 3 to about 14 days in the presence of an anti-CD3 antibody and an anti-CD28 antibody under conditions appropriate for activating cytotoxic T cells,

wherein the reducing and culturing activates and induces proliferation of activated T cells to yield a population comprising activated T cells in sufficient numbers for use in therapy.

2. The method of claim 1 , wherein the T cells are selected from the group consisting of a leukocyte-containing cell mixture and a purified T cell population.

3. The method of claim 2 , wherein the leukocyte-containing cell mixture or purified T cell population is obtained from apheresis of peripheral blood of a human subject.

4. The method of claim 2 , wherein the leukocyte-containing cell mixture or purified T cell population is obtained from peripheral blood mononuclear cells of a human subject.

5. The method of claim 1 , wherein the population comprises at least one of activated CD4 + T cells and CD8 + T cells.

6. The method of claim 1 , wherein cytotoxic CD8 + T cells are preferentially expanded from the activated T cell population.

7. The method of claim 1 , wherein the method of step (a) is selected from the group consisting of:

(i) culturing T cells in the presence of a BAFF-R antagonist; and

(ii) contacting T cells with a BAFF-R specific shRNA.

8. The method of claim 7 , wherein the BAFF-R antagonist is a neutralizing BAFF-R antibody.

9. A method of claim 1 additionally comprising the step of:

(c) providing in the T cells a chimeric antigen receptor, to generate a population of activated T cells comprising the chimeric antigen receptor.

10. The method of claim 9 , wherein the providing step (c) comprises a method step selected from the group consisting of:

(i) introducing the chimeric antigen receptor into the T cells; and

(ii) transfecting a nucleic acid vector encoding the chimeric antigen receptor into the T cells whereby the T cells express the chimeric antigen receptor.

11. The method of claim 9 , wherein the reducing step (a) comprises a method step selected from the group consisting of:

(i) culturing T cells in the presence of a BAFF-R antagonist; and

(ii) contacting T cells with a BAFF-R specific shRNA.

12. The method of claim 11 , wherein the BAFF-R antagonist is a neutralizing BAFF-R antibody.

13. A method of preparing a population of T cells, the method comprising

(a) reducing BAFF-R receptor activity in the T cells; and

(b) culturing the T cells of (a) for about 3 to about 14 days in the presence of an anti-CD3 antibody, or a CD3-binding fragment thereof, and an anti-CD28 antibody, or a CD28-binding fragment thereof, under conditions appropriate for activating cytotoxic T cells,

wherein the reducing and culturing activates and induces proliferation of activated T cells to yield a population comprising activated T cells in sufficient numbers for use in therapy.

14. The method of claim 13 , wherein the anti-CD3 antibody is an anti-CD3ε antibody.

15. The method of claim 14 , wherein the anti-CD3ε antibody is selected from the group consisting of clone UCHT1 and clone OKT3.

16. The method of claim 13 , wherein the anti-CD28 antibody is selected from the group consisting of clone 37407 and clone 9.3.

17. The method of claim 13 , wherein the anti-CD3 and anti-CD28 antibodies are attached to a substrate.

18. The method of claim 17 , wherein the substrate is a plate or a bead.

19. The method of claim 13 , wherein the T cells are selected from the group consisting of a leukocyte-containing cell mixture and a purified T cell population.

20. The method of claim 19 , wherein the leukocyte-containing cell mixture or purified T cell population is obtained from apheresis of peripheral blood of a human subject.

21. The method of claim 13 , wherein the population comprises at least one of activated CD4 + T cells and CD8 + T cells.

22. The method of claim 13 , wherein the method of step (a) is selected from the group consisting of:

(i) culturing T cells in the presence of a BAFF-R antagonist; and

(ii) contacting T cells with a BAFF-R specific shRNA.

23. The method of claim 22 , wherein the BAFF-R antagonist is a neutralizing BAFF-R antibody.

24. A method of claim 13 additionally comprising the step of:

(c) providing in the T cells a chimeric antigen receptor, to generate a population of activated T cells comprising the chimeric antigen receptor.

25. The method of claim 24 , wherein the providing step (c) comprises a method step selected from the group consisting of:

(i) introducing the chimeric antigen receptor into the T cells; and

(ii) transfecting a nucleic acid vector encoding the chimeric antigen receptor into the T cells whereby the T cells express the chimeric antigen receptor.

26. The method of claim 24 , wherein the reducing step (a) comprises a method step selected from the group consisting of:

(i) culturing T cells in the presence of a BAFF-R antagonist; and

(ii) contacting T cells with a BAFF-R specific shRNA.

27. The method of claim 26 , wherein the BAFF-R antagonist is a neutralizing BAFF-R antibody.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jul 3, 2018
From: UNIVERSITY OF WISCONSIN MADISON
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 046483/0751 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 4, 2017
From: HEMATTI, PEIMAN; BLOOM, DEBRA
To: WISCONSIN ALUMNI RESEARCH FOUNDATION
Reel/Frame 041847/0255 →
Continuity (2)
Provisional Application 62307989 · Mar 14, 2016
Related Publication 20170260506A1 · Sep 14, 2017