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.
The FDA agreed with the findings of the safety investigation and removed the hold on Allogene’s clinical trials, the company said.
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