IP Library Granted Patent US 11,351,196
Granted Patent B2
US 11,351,196 · App. 17/151,085 · Granted Jun 7, 2022

Generating CIK NKT cells from cord blood

Inventors: Rohit Duggal (San Diego, CA); Ranjeet Sinha (San Diego, CA)
Assignee: ImmunityBio, Inc.
A61K35/17A61K9/0019A61K39/395C12N5/0646C12N2501/2302C12N2501/2307C12N2501/2315C12N2501/26C12N2501/998
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Quick Facts
Patent No.
US 11,351,196
App. No.
17/151,085
Granted
Jun 7, 2022
Kind
B2
Abstract

Provided herein are methods and customized media compositions for culturing CIK NKT cells.

Claims (27)

1. A method of obtaining CIK NKT cells from a cord blood sample, the method comprising:

isolating mononuclear cells from the cord blood sample; and

contacting the isolated mononuclear cells with i) IL-7, ii) ALT-803 or IL-15, iii) FLT3 ligand, and iv) Gal-Cer, thereby producing a population of CIK NKT cells greater than 90% of which express CD56 and CD3 and less than 10% of which express Va24.

2. The method of claim 1 , wherein the IL-7 is present in a concentration ranging from 5 to 20 ng/mL.

3. The method of claim 1 , wherein the ALT-803, if present, is in a concentration ranging from 100 to 300 ng/mL.

4. The method of claim 1 , wherein the FLT3 ligand is present in a concentration ranging from 5 to 20 ng/mL.

5. The method of claim 1 , wherein the Gal-Cer is present in a concentration ranging from 2 to 10 μg/mL.

6. The method of claim 1 , wherein the method further comprises isolating the enriched CIK NKT cells from the rest of the cord blood sample.

7. The method of claim 6 , wherein the method further comprises expanding the isolated CIK NKT cells with anti-CD3, anti-CD28, and IL2.

8. The method of claim 7 , wherein the Gal-Cer is a present in a form of a Gal-Cer loaded CD1d tetramer.

9. The method of claim 7 , wherein the anti-CD3 antibody is present in an amount of 5 ng/mL to 60 ng/mL.

10. The method of claim 7 , wherein the anti-CD28 antibody is present in an amount of 0.1 μg/mL to 2 μg/mL.

11. The method of claim 7 , wherein IL-2 is present in a concentration of 50 ng/mL to 500 ng/mL.

12. The method of claim 7 , wherein the production of CIK NKT cells does not include interferon-gamma.

13. The population of CIK NKT cells produced by the method of claim 1 , wherein the CIK NKT cells express a CAR and/or a cytokine.

14. The method of claim 7 , wherein the population of expanded CIK NKT cells comprise cytotoxic effector cells that are cytotoxic in the absence of Gal-Cer.

15. The method of claim 7 , wherein greater than 90% of the population of expanded CIK NKT cells express CD56 and CD3, and less than 10% of the population express Va24.

16. A population of CIK NKT cells produced by the method of claim 1 , wherein greater than 90% of the cells in the population express CD56 and CD3 and less than 10% of the cells in the population express Va24.

17. The population of CIK NKT cells of claim 16 , wherein the CIK NKT cells can kill a target cell in the absence of alpha-galactosylceramide(Gal-Cer).

18. The population of CIK NKT cells of claim 17 , wherein the CIK NKT cells kill a plurality of the target cells at an EC50 of between 1.0 and 10.0.

19. The population of CIK NKT cells of claim 18 , wherein the CIK NKT cells can kill the target cells at a EC50 that is no less than 90% and no greater than 110% of the EC50 at which the CIK NKT cells killing the target cells in the presence of Gal-Cer.

20. The population of CIK NKT cells of claim 16 , wherein the target cell is a cancer cell.

21. The population of CIK NKT cells of claim 20 , wherein the cancer cell is selected from the group consisting of a K562 cell, a Daudi cell, a DAOY cell, and a THP-1 cell.

22. The population of CIK NKT cells of claim 16 , wherein the cancer cell line is selected from the group consisting of a myelogenous leukemia cell, a medulloblastoma cell, and a monocytic cell.

23. A composition comprising a plurality of CIK NKT cells from the population of CIK NKT cells of claim 16 , and a physiologically acceptable excipient.

24. A kit for treating cancer comprising a plurality of CIK NKT cells from the population of CIK NKT cells of claim 16 , wherein the kit further includes a container and/or a label indicating the kit is for treating cancer.

25. A method of enriching CIK NKT cells from a cord blood sample, the method comprising: 1) isolating mononuclear cells from the cord blood sample; and contacting the isolated mononuclear cells with IL-7, ALT-803 or IL-15, or FLT3 ligand, and Gal-Cer, thereby enriching the CIK NKT cells; 2) isolating the enriched CIK NKT cells from the rest of the cord blood sample; and 3) expanding the isolated CIK NKT cells with anti-CD3, anti-CD28, IL2, and Gal-Cer; thereby producing a population of CIK NKT cells greater than 90% of which express CD56 and CD3 and less than 10% of which express Va24.

Assignments (3)
SECURITY INTEREST Recorded Jan 2, 2024
From: IMMUNITYBIO, INC.; NANTCELL, INC.; RECEPTOME, INC.; VBC HOLDINGS LLC; ALTOR BIOSCIENCE, LLC; ETUBICS CORPORATION; IGDRASOL, INC.
To: INFINITY SA LLC, AS PURCHASER AGENT
Reel/Frame 066179/0074 →
CHANGE OF NAME Recorded Aug 2, 2021
From: NANTKWEST, INC.
To: IMMUNITYBIO, INC.
Reel/Frame 057059/0802 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 26, 2021
From: DUGGAL, ROHIT; SINHA, RANJEET
To: NANTKWEST, INC.
Reel/Frame 055040/0399 →
Continuity (3)
Continuation 17260544
Provisional Application 62696131 · Jul 10, 2018
Related Publication 20210205367A1 · Jul 8, 2021