	US 11,779,601 B2
	Diagnostic methods for T cell therapy
Adrian Bot, Santa Monica, CA (US); Jeffrey S. Wiezorek, Santa Monica, CA (US); William Go, Santa Monica, CA (US); Rajul Jain, Santa Monica, CA (US); James N. Kochenderfer, Bethesda, MD (US); and Steven A. Rosenberg, Bethesda, MD (US)
Assigned to Kite Pharma, Inc., Santa Monica, CA (US); and The United States of America as represented by the Secretary, Department of Health and Human Services, Bethesda, MD (US)
Appl. No. 15/577,672
Filed by Kite Pharma, Inc., Santa Monica, CA (US); and United States of America, as represented by the Secretary, Department of Health and Human Services, Rockville, MD (US)
PCT Filed May 27, 2016, PCT No. PCT/US2016/034885 § 371(c)(1), (2) Date Nov. 28, 2017, PCT Pub. No. WO2016/191755, PCT Pub. Date Dec. 1, 2016.
Claims priority of provisional application 62/262,111, filed on Dec. 2, 2015.
Claims priority of provisional application 62/167,738, filed on May 28, 2015.
Prior Publication US 2018/0344767 A1, Dec. 6, 2018
Int. Cl. A61K 35/17 (2015.01); C12N 5/0783 (2010.01); C07K 14/52 (2006.01); G01N 33/68 (2006.01); A61P 35/00 (2006.01); C07K 14/00 (2006.01); C12N 15/00 (2006.01); A61K 31/095 (2006.01); A61K 31/445 (2006.01); A61K 31/52 (2006.01); A61K 31/665 (2006.01); A61K 45/06 (2006.01); C12N 15/85 (2006.01)

CPC A61K 35/17 (2013.01) [A61K 31/095 (2013.01); A61K 31/445 (2013.01); A61K 31/52 (2013.01); A61K 31/665 (2013.01); A61K 45/06 (2013.01); A61P 35/00 (2018.01); C07K 14/00 (2013.01); C07K 14/52 (2013.01); C12N 5/0636 (2013.01); C12N 15/00 (2013.01); C12N 15/85 (2013.01); G01N 33/6869 (2013.01); A61K 2300/00 (2013.01); C12N 2510/00 (2013.01); G01N 2333/5418 (2013.01); G01N 2333/5443 (2013.01)]

13 Claims

1. A method for treating a lymphoma in a patient suitable for chimeric antigen receptor (CAR) T cell therapy comprising:

(i) administering to the patient one or more preconditioning agents that are capable of decreasing the serum level of Perforin and increasing a serum level of interleukin-15 (“IL-15”), interleukin-7 (“IL-7”), and of at least one additional cytokine selected from the group consisting of monocyte chemotactic protein 1 (“MCP-1”), C-reactive protein (“CRP”), placental growth factor (“PLGF”), interferon gamma-induced protein 10 (“IP-10”), and any combination thereof, wherein the preconditioning agents comprise cyclophosphamide and fludarabine;

and (ii) administering a therapeutically effective amount of anti-CD19 CAR T cell therapy on day zero, wherein the patient has been determined to exhibit a decrease in the serum level of Perforin and an increased serum level of IL-15, IL-7, and the at least one additional cytokine, at day zero, prior to the administration of CAR T cell therapy and relative to their baseline serum levels, wherein the cytokine serum levels have been measured by an enzyme-linked immunosorbent assay (ELISA) or any method that detects the amount of protein in the serum for each cytokine and allows for their quantification, prior to the administration of the preconditioning agents.