Business
Allogene Therapeutics Reports FDA Clinical Hold of AlloCAR T Trials Based on a Single Patient Case in ALPHA2 Trial
Testing in a Patient with Low Blood Counts Showed a Chromosomal Abnormality in ALLO-501A CAR T Cells of Unclear Clinical Significance; Patient Achieved a
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"Testing in a Patient with Low Blood Counts Showed a Chromosomal Abnormality in ALLO-501A CAR T Cells of Unclear Clinical Significance; Patient Achieved a Partial Response to TherapyInvestigation Ongoing to Further Characterize the Finding, Including Any Clinical Relevance, Evidence of Clonal Expansion, or Potential Relationship to Gene EditingCompany Believes Data from the ALPHA Trials Demonstrates a Favorable Clinical Profile of ALLO-501AFDA Continues to Review End of Phase 1 Materials for a Phase 2 Pivotal Trial of ALLO-501ACompany to Host Conference Call Today at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today reported that following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, the U.S. Food and Drug Administration (FDA) has placed a hold on the Company’s AlloCAR T clinical trials. The Company expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 trial. “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, and determine next steps for advancing ALLO-501A and our clinical programs,” said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “As a leading developer of allogeneic cell therapies, we recognize our added responsibility to fully assess all aspects of our therapies to advance the field. We are grateful for the partnership with the patient community, clinical investigators, our Scientific Advisory Board, and the FDA as we work diligently toward understanding the clinical significance of this finding and to support the development of allogeneic CAR T therapy for cancer.” The clinical hold follows the Company’s notification to the FDA of a chromosomal abnormality in an ALPHA2 study patient which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts). An investigation is underway to further characterize the o...