STAT+: FDA halts Allogene blood cancer trials after patient found to have ‘chromosomal abnormality’
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.
