STAT+: FDA removes clinical hold on cancer studies of Allogene off-the-shelf CAR-T treatment

Allogene said Monday that clinical trials involving its off-the-shelf CAR-T therapies for blood cancer are resuming following a safety clearance by U.S. regulators.

In October, the Food and Drug Administration placed five Allogene studies on hold after a single treated patient was found to have a “chromosomal abnormality.” But a three-month investigation conducted by Allogene concluded its CAR-T called ALLO-501A was not responsible for the chromosomal abnormality, and that it had no clinical significance for the patient.

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