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Allogene Therapeutics said Thursday that the Food and Drug Administration had placed a hold on its clinical trials after a patient with blood cancer treated with its off-the-shelf CAR-T cell therapy was found to have a “chromosomal abnormality.”

An investigation is underway to determine what might have caused the unexpected changes to the engineered T cells that make up the Allogene treatment, the company said. At this time, the clinical significance to the patient remains unclear.


“Patient safety is our highest priority, and we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding,” said Allogene Chief Medical Officer Rafael Amado.

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