US 12,031,975 B2
Methods of assessing or monitoring a response to a cell therapy
Trevor Do, Seattle, WA (US); Howard Stern, Seattle, WA (US); and Christina Swanson, Seattle, WA (US)
Assigned to Juno Therapeutics, Inc., Seattle, WA (US)
Appl. No. 16/760,381
Filed by Juno Therapeutics, Inc., Seattle, WA (US)
PCT Filed Oct. 31, 2018, PCT No. PCT/US2018/058596
§ 371(c)(1), (2) Date Apr. 29, 2020,
PCT Pub. No. WO2019/089858, PCT Pub. Date May 9, 2019.
Claims priority of provisional application 62/685,250, filed on Jun. 14, 2018.
Claims priority of provisional application 62/673,825, filed on May 18, 2018.
Claims priority of provisional application 62/596,733, filed on Dec. 8, 2017.
Claims priority of provisional application 62/580,430, filed on Nov. 1, 2017.
Prior Publication US 2021/0132042 A1, May 6, 2021
Int. Cl. G01N 33/50 (2006.01); A61K 35/17 (2015.01); C07K 14/705 (2006.01)
CPC G01N 33/5017 (2013.01) [A61K 35/17 (2013.01); C07K 14/705 (2013.01); G01N 33/5091 (2013.01); G01N 2333/70514 (2013.01); G01N 2800/52 (2013.01)] 33 Claims
 
1. A method of treatment, the method comprising administering a therapeutic regimen to a subject, that is a candidate for receiving a cell therapy for treatment of non-Hodgkin lymphoma (NHL) but that has not yet been administered the cell therapy, following assessment of a tumor sample from the subject for frequency of CD4+T cells compared to a threshold value, wherein frequency of CD4+T cells above the threshold value indicates the subject is likely to achieve a response when administered the cell therapy and a frequency of CD4+T cells below the threshold value indicates the subject is not likely to achieve a response when administered the cell therapy, wherein:
if the frequency of CD4+T cells is above the threshold level, administering the cell therapy to the subject; and
if the frequency of CD4+T cells is below the threshold level, administering (i) an agent or other treatment capable of stimulating, amplifying, potentiating, and/or enhancing an anti-tumor immune response and the cell therapy; (ii) the cell therapy at an increased dose and/or administering an additional dose of the cell therapy; or (iii) an alternative therapeutic treatment other than the cell therapy.