Allogene Therapeutics saw its shares fall more than 40% in early trading Friday after acknowledging that the FDA had placed a clinical hold on its trials evaluating its allogeneic CAR T (AlloCAR T) therapies for cancer.
Allogene said the clinical hold was placed after it notified the FDA of a chromosomal abnormality detected in a bone marrow biopsy undertaken to assess pancytopenia in a patient who was treated with the company’s ALLO-501A CAR T cells in the Phase I/II ALPHA2 trial (NCT04416984).