US 11,747,346 B2
Biomarkers predictive of cytokine release syndrome
Alfred Garfall, Wallingford, PA (US); Alex Ganetsky, Philadelphia, PA (US); Saar Gill, Philadelphia, PA (US); Simon Lacey, Media, PA (US); Jan J. Melenhorst, Moreland Hills, OH (US); David Teachey, Rutledge, PA (US); Eric Lancaster, Wynnewood, PA (US); Adam David Cohen, Bala Cynwyd, PA (US); and Pamela Shaw, Seattle, WA (US)
Assigned to Novartis AG, Basel (CH); and The Trustees of the University of Pennsylvania, Philadelphia, PA (US)
Appl. No. 15/757,123
Filed by The Trustees of the University of Pennsylvania, Philadelphia, PA (US); Alfred Garfall, Wallingford, PA (US); Alex Ganetsky, Philadelphia, PA (US); Saar Gill, Philadelphia, PA (US); Simon Lacey, Media, PA (US); Jan J. Melenhorst, Cherry Hill, NJ (US); and David Teachey, Rutledge, PA (US)
PCT Filed Sep. 2, 2016, PCT No. PCT/US2016/050112
§ 371(c)(1), (2) Date Mar. 2, 2018,
PCT Pub. No. WO2017/040930, PCT Pub. Date Mar. 9, 2017.
Claims priority of provisional application 62/381,153, filed on Aug. 30, 2016.
Claims priority of provisional application 62/263,235, filed on Dec. 4, 2015.
Claims priority of provisional application 62/214,066, filed on Sep. 3, 2015.
Prior Publication US 2018/0252727 A1, Sep. 6, 2018
Int. Cl. G01N 33/53 (2006.01); G01N 33/68 (2006.01); G01N 33/50 (2006.01); A61P 37/00 (2006.01); A61P 29/00 (2006.01); A61K 31/675 (2006.01); A61K 35/17 (2015.01); A61K 39/395 (2006.01); A61K 45/06 (2006.01); C07K 14/725 (2006.01); C07K 14/705 (2006.01); C07K 16/28 (2006.01); C12Q 1/6876 (2018.01)
CPC G01N 33/6863 (2013.01) [A61K 31/675 (2013.01); A61K 35/17 (2013.01); A61K 39/3955 (2013.01); A61K 45/06 (2013.01); A61P 29/00 (2018.01); A61P 37/00 (2018.01); C07K 14/7051 (2013.01); C07K 14/70578 (2013.01); C07K 16/2803 (2013.01); C12Q 1/6876 (2013.01); G01N 33/5047 (2013.01); G01N 33/6866 (2013.01); G01N 33/6869 (2013.01); G01N 33/6893 (2013.01); C07K 2317/622 (2013.01); C07K 2317/76 (2013.01); C07K 2319/02 (2013.01); C07K 2319/03 (2013.01); C12Q 2600/106 (2013.01); C12Q 2600/158 (2013.01); G01N 2800/24 (2013.01); G01N 2800/50 (2013.01); G01N 2800/52 (2013.01); G01N 2800/7095 (2013.01)] 25 Claims
 
1. A method for treating a subject having a cancer, comprising:
administering to the subject a therapeutically effective dose of a CAR-expressing cell therapy, and
measuring the level or activity of soluble gp130 (sgp130) in a sample from the subject to determine a cytokine release syndrome (CRS) risk status comprising a measure of the level or activity of sgp130, wherein the CRS risk status is indicative of the subject's risk for developing CRS, wherein the subject is identified as being at risk of developing CRS if the level or activity of sgp130 is greater than a reference level or activity; and
responsive to a determination of the CRS risk status,
administering to the subject a second therapy comprising one or more of: an IL6 inhibitor, a vasoactive medication, an immunosuppressive agent, a corticosteroid, or mechanical ventilation if the level or activity of sgp130 is greater than the reference level or activity.