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.
According to Cellectis, investigators are still piecing together the underlying cause of the cardiac arrest. The patient had been unsuccessfully treated with numerous cancer therapies, including traditional CAR-T, and was on a higher dose of the off-the-shelf therapy than Cellectis is using in a later-stage trial.
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