Shots:

• The US FDA has placed a clinical hold on the ALPHA2 study that evaluates ALLO-501A CAR T in 100+ patients with large B-cell lymphoma
• The discontinuation is due to the observation of chromosomal abnormality in ALLO-501A CAR T cells which was detected in a bone marrow biopsy to test the patient with low blood counts. Additionally- the investigation is underway to identify the abnormality including clinical relevance- clonal expansion- or gene editing
• The company expects to provide additional updates in the coming wks.- following the US FDA’s discussion. The FDA continues to review the P-I data to further supports the P-II ALLO-501A trial

  | Ref: Allogene | Image: Allogene