FDA puts clinical hold on Cellectis CAR-T trial after patient dies of cardiac arrest


The FDA put a clinical hold on French drugmaker Cellectis' trial for its off-the-shelf CAR-T therapy after a patient died of cardiac arrest, the company said July 6. 

The trial was for a treatment called UCARTCS1A. Off-the-shelf CAR-T treatments are derived from T cells provided by healthy donors and are supposed to be less dangerous than traditional CAR-T therapies, which are made from patients' own immune cells, according to STAT. The patient death happened in a multiple myeloma trial and suggests that off-the-shelf CAR-T treatments may also be risky. 

Cellectis said investigators are working to determine the underlying cause of the patient's cardiac arrest. The patient had been previously treated with numerous cancer therapies, including traditional CAR-T, and was on a higher dose of the off-the-shelf CAR-T therapy than Cellectis used in a larger trial, the drugmaker said. 

Cellectis' shares fell 18 percent after the announcement of the clinical hold, Endpoints News reported. 

Cellectis said it's working closely with the FDA to address the agency's requested changes to the clinical protocol to improve patient safety. 

Read the full news release here.

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