FDA lifts clinical hold on Allogene’s CAR T-cell therapy trials
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The FDA lifted its clinical hold on a series of trials that use Allogene Therapeutics’ AlloCAR T chimeric antigen receptor T-cell therapies, according to a press release from the manufacturer.
Allogene announced the hold in October 2021 based on the report of one patient with pretreated stage IV follicular lymphoma who showed evidence of a chromosomal abnormality after receiving the company’s ALLO-501A CAR T cells as part of the ALPHA2 study.
AlloCAR T are allogeneic CAR T cells derived from induced pluripotent stem cells from healthy donors that are genetically modified using transcription activator-like effector nucleases (TALEN) gene-editing technology.
“Investigations concluded that the chromosomal abnormality was unrelated to TALEN gene editing or Allogene’s manufacturing process and had no clinical significance,” a company-issued press release read. “The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot.”
The clinical hold affected five trials in the AlloCAR T portfolio for relapsed or refractory cancers, including therapies designed to treat non-Hodgkin lymphoma, multiple myeloma and renal cell carcinoma.
Activity across all five trials is expected to resume after coordination with site investigators. Allogene also plans to initiate a pivotal phase 2 trial of ALLO-501A for patients with relapsed or refractory large B-cell lymphoma by the middle of this year, pending final approval from the FDA.
“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 [response],” Rafael Amado, MD, executive vice president of research and development and chief medical officer with Allogene, said in the release.
“Allogeneic CAR-T 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,” Amado added. “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.”
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