
The Food and Drug Administration has placed a clinical hold on one of Cellectis’s off-the-shelf CAR-T trials after one patient died of cardiac arrest, a worrying development for a technology thought to be safer than the approved alternative.
Cellectis’s treatment, UCARTCS1A, is derived from T cells provided by healthy donors, more practical and potentially less dangerous than traditional CAR-T therapies made from patients’ own immune cells. But the patient death, which emerged in a multiple myeloma study, suggests off-the-shelf CAR-T could carry risks of its own.