	US 11,740,231 B2
	Articles of manufacture and methods related to toxicity associated with cell therapy
Nathan Yee, Seattle, WA (US); Christopher Glen Ramsborg, Seattle, WA (US); Tina Albertson, Seattle, WA (US); Ryan Larson, Seattle, WA (US); and He Li, Seattle, WA (US)
Assigned to Juno Therapeutics, Inc., Seattle, WA (US)
Appl. No. 16/617,477
Filed by Juno Therapeutics, Inc., Seattle, WA (US)
PCT Filed Jun. 1, 2018, PCT No. PCT/US2018/035752 § 371(c)(1), (2) Date Nov. 26, 2019, PCT Pub. No. WO2018/223098, PCT Pub. Date Dec. 6, 2018.
Claims priority of provisional application 62/515,526, filed on Jun. 5, 2017.
Claims priority of provisional application 62/514,762, filed on Jun. 2, 2017.
Prior Publication US 2020/0110077 A1, Apr. 9, 2020
Int. Cl. G01N 33/50 (2006.01); A61P 35/00 (2006.01); A61K 35/17 (2015.01); C07K 14/725 (2006.01); C07K 14/705 (2006.01); C07K 16/28 (2006.01); C12N 5/0783 (2010.01); G01N 33/574 (2006.01)

CPC G01N 33/5091 (2013.01) [A61K 35/17 (2013.01); A61P 35/00 (2018.01); C07K 14/7051 (2013.01); C07K 14/70521 (2013.01); C07K 14/70578 (2013.01); C07K 16/2803 (2013.01); C12N 5/0636 (2013.01); G01N 33/5047 (2013.01); G01N 33/57407 (2013.01); C07K 2319/02 (2013.01)]

33 Claims

1. A method of selecting a subject for treatment, the method comprising:

(a) contacting an apheresis sample with a reagent capable of detecting CD14+ myeloid cells, wherein:

the apheresis sample is from a subject that is a candidate for treatment with a cell therapy comprising a dose of genetically engineered cells expressing a recombinant receptor; and

the apheresis sample is obtained from the subject prior to administering the cell therapy; and

(b) selecting for treatment a subject in which:

i) the percentage of cells in the sample that are surface positive for CD14 is at or above a threshold level of at least 20%, thereby identifying a subject that is at risk for developing a neurotoxicity to the cell therapy; and

(c) administering an agent capable of treating, preventing, delaying, reducing, or attenuating the development of a neurotoxicity and the cell therapy to the subject.