Allogene: FDA Lifts Clinical Hold Across AlloCAR T Studies

By Colin Kellaher

Allogene Therapeutics Inc. on Monday said the U.S. Food and Drug Administration has removed the clinical hold on all of the biotechnology company's AlloCAR T clinical trials after investigations found that a chromosomal abnormality detected in a single patient was unrelated to the company's Talen gene editing or manufacturing process and had no clinical significance.

The South San Francisco, Calif., company reported in October that the FDA had placed the hold on all five of its clinical trials based on a report of a chromosomal abnormality detected post-AlloCAR T administration in the patient, who had been treated with ALLO-501A.

However, the company on Monday said the abnormality wasn't detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot.

Allogene said it plans to resume clinical trials across the platform, with a pivotal Phase 2 study of ALLO-501A in relapsed/refractory large B cell lymphoma to begin mid-year, pending final discussions with the FDA.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 10, 2022 09:08 ET (14:08 GMT)

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