US 12,458,654 B2
Methods of conditioning patients for T cell therapy
Adrian Bot, Santa Monica, CA (US); Jeffrey 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 United States of America, as represented by the Secretary, Department of Health and Human Services, Rockville, MD (US)
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)
Filed on Sep. 27, 2022, as Appl. No. 17/954,070.
Application 17/954,070 is a continuation of application No. 15/950,042, filed on Apr. 10, 2018, granted, now 11,491,187.
Application 15/950,042 is a continuation of application No. 15/649,369, filed on Jul. 13, 2017, granted, now 10,322,146, issued on Jun. 18, 2019.
Application 15/649,369 is a continuation of application No. 15/167,977, filed on May 27, 2016, granted, now 9,855,298, issued on Jan. 2, 2018.
Claims priority of provisional application 62/262,143, filed on Dec. 2, 2015.
Claims priority of provisional application 62/167,750, filed on May 28, 2015.
Prior Publication US 2023/0158075 A1, May 25, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/664 (2006.01); A61K 31/675 (2006.01); A61K 31/7076 (2006.01); A61K 38/20 (2006.01); A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/42 (2025.01); A61K 45/06 (2006.01); A61P 35/02 (2006.01)
CPC A61K 31/664 (2013.01) [A61K 31/675 (2013.01); A61K 31/7076 (2013.01); A61K 38/2013 (2013.01); A61K 38/2053 (2013.01); A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/4211 (2025.01); A61K 45/06 (2013.01); A61P 35/02 (2018.01); A61K 2239/31 (2023.05); A61K 2239/38 (2023.05); A61K 2239/48 (2023.05)] 12 Claims
 
1. A method of treating a patient having a tumor comprising (i) administering to the patient a single dose of cyclophosphamide at about 900 mg/m2/day and one or more doses of fludarabine at about 25 mg/m2/day; and (ii) administering to the patient a therapeutically effective amount of engineered chimeric antigen receptor (CAR) T cells, wherein the patient is determined to have an increase in the serum levels of IL-15 of at least 5-fold, IL-7 of at least 2-fold, and an increase in at least one of MCP-1 or CRP of at least 1.5 fold or IP-10 of at least 2-fold on the day of but prior to administration of the CAR-T cells, after the administration of cyclophosphamide and fludarabine; wherein the tumor is a leukemia and the engineered CAR-T cells are anti-CD19 CAR-T cells.