Allogene’s AlloCAR-T Programs Placed on Clinical Hold by the FDA

On Thursday, October 7, Allogene announced (press release) that the FDA has placed a clinical hold on all of Allogene’s AlloCAR-T trials, with the company providing additional insights via a webcast. Of note, the FDA ordered the clinical hold following a reported chromosomal abnormality event from a patient treated with ALLO-501A (allogeneic CD19 CAR-T) in the Ph1/2 ALPHA-2 study for r/r LBCL. Additionally, on Friday, October 8, Precision BioSciences released a statement (press release) highlighting the safety of their allogeneic CAR-T approach. Below, Celltelligence provides insights on the potential impact of the clinical hold, while discussing how other companies developing gene-edited allogeneic therapies could be affected.

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