FDA puts three CARs­gen CAR-T ther­a­pies on clin­i­cal hold, in­clud­ing Mod­er­na-part­nered pro­gram

Ques­tions re­lat­ed with chem­istry, man­u­fac­tur­ing and con­trols have trig­gered clin­i­cal holds for three of CARs­gen Ther­a­peu­tics’ CAR-T ther­a­pies, the biotech dis­closed on Tues­day.

The holds are halt­ing tri­als for CT053, CT041 and CT071, which tar­get BC­MA, Claudin18.2 and GPRC5D, re­spec­tive­ly. CARs­gen, which has op­er­a­tions in both the US and Chi­na, had col­lab­o­rat­ed with Mod­er­na to test CT041 in com­bi­na­tion with Mod­er­na’s mR­NA can­cer vac­cine, al­though it ap­pears the work is still in pre­clin­i­cal stage.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER