A Cellectis Trial Death Points To Challenges Ahead For CAR-T

Excitement over the emerging cancer immunotherapy approach has been super-charged in recent weeks, but Cellectis said it will put two trials on hold after a patient death, a problem seen with similar products.

Stop barrier

Cellectis SA is one of the companies that has benefited from investor enthusiasm over chimeric antigen receptor T cell (CAR-T) therapy in the last week, but its clinical-stage development program has been hit with a reality check. The company announced Sept. 4 that FDA placed a clinical hold on two Phase I studies testing its lead CAR-T candidate UCART 123 after a patient death was reported in one of the trials.

"Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol...

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