Allogene Therapeutics Announces Removal of FDA Clinical Hold Across All AlloCAR T™ Clinical Trials

  • Investigation Confirmed the Chromosomal Abnormality in a Single Patient was Not Observed in Any AlloCAR T Product and Not Related to Allogene Manufacturing Process or TALEN® Gene Editing
  • Clinical Trials Across the AlloCAR T Platform to Resume
  • Pivotal Phase 2 Trial of ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Expected to Commence in Mid-Year 2022 Pending FDA Discussions

SOUTH SAN FRANCISCO, CA, USA I January 10, 2022 I Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on all of the Company’s AlloCAR T clinical trials. Allogene previously announced on October 7, 2021 that the FDA had placed a hold on all five of the Company’s AlloCAR T clinical trials based on a report of a chromosomal abnormality detected post-AlloCAR T administration in a single patient treated with ALLO-501A in the ALPHA2 study.

Investigations concluded that the chromosomal abnormality was unrelated to TALEN® gene editing or Allogene’s manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T cell or B cell maturation process.

Allogene will be working with clinical trial investigators to resume study activities across AlloCAR T development programs as quickly as possible. Pending final discussions with the FDA, the Company also plans to initiate its pivotal Phase 2 trial of ALLO-501A in relapsed/refractory Large B Cell Lymphoma (LBCL) mid-year 2022.

“We are thankful for the partnership between our teams at Allogene, our clinical trial investigators who remain steadfast in their support of our investigational therapies, and the FDA which expeditiously completed its review of our Complete Response Letter,” said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. “Allogeneic CAR T therapy is a rapidly developing field that continues to evolve both in scope and impact, and the findings from our investigation will help advance innovation in the fields of gene editing and cell and gene therapy. As the leading developer of allogeneic cell products, we look forward to resuming our clinical trials as we work to fulfill our commitment to bring patients the first allogeneic CAR T product.”

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

SOURCE: Allogene Therapeutics

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