	US 12,480,951 B2
	Methods and compositions for T cell therapy
Adrian I. Bot, Beverly Hills, CA (US); Justin Budka, Fishers, IN (US); Szu-Ting Chou, Los Angeles, CA (US); Francesca Milletti, Manhattan Beach, CA (US); Vicki Plaks, Santa Monica, CA (US); and John M. Rossi, Newbury Park, CA (US)
Assigned to Kite Pharma, Inc., Santa Monica, CA (US)
Filed by Kite Pharma, Inc., Santa Monica, CA (US)
Filed on Jan. 7, 2022, as Appl. No. 17/570,917.
Claims priority of provisional application 63/135,711, filed on Jan. 10, 2021.
Prior Publication US 2022/0221463 A1, Jul. 14, 2022
Int. Cl. A61P 35/00 (2006.01); A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/42 (2025.01); C12N 5/0783 (2010.01); G01N 33/50 (2006.01); G01N 33/574 (2006.01)

CPC G01N 33/57492 (2013.01) [A61K 40/11 (2025.01); A61K 40/31 (2025.01); A61K 40/4211 (2025.01); A61P 35/00 (2018.01); C12N 5/0636 (2013.01); G01N 33/5094 (2013.01)]

15 Claims

1. A method for treating a hematological cancer in a patient comprising:

measuring a level of CD27+CD28+ naïve CD4+ T helper (Th) cells in an apheresis product from said patient;

and

administering an effective dose of T cells comprising a chimeric antigen receptor if the level of CD27+CD28+ naïve CD4+ Th cells is over a cut-off percentage value measured as a percentage of total leukocytes, or administering an effective dose of T cells comprising the chimeric antigen receptor and a combination therapy if the level of CD27+CD28+ naïve CD4+ Th cells is below said cut-off percentage value,

wherein said cut-off percentage value is between 0.1%-0.5%, and

wherein chimeric antigen receptor comprises an anti-CD19 single chain variable fragment (scFv).