FDA lifts hold on Allogene’s CAR-T trials

Jan. 11, 2022

The U.S. FDA has lifted the clinical hold on San Francisco based-Allogene Therapeutics’ cancer cell therapy trials, called AlloCAR T, the company announced.

The FDA found that a previously reported chromosomal abnormality was not caused by Allogene’s gene editing or manufacturing process. Allogene plans to resume activities and development programs as quickly as possible.

The company’s clinical trials of AlloCAR T were placed on hold by the FDA in October 2021, Allogene revealed, following a report to the FDA of a chromosomal abnormality detected in the bone marrow of a study patient with stage IV lymphoma. According to Allogene, the patient experienced a reaction requiring a high dose of steroid therapy, then developed progressive pancytopenia and aplastic anemia. The investigation found that the abnormality was unrelated to Allogene’s manufacturing process.

“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,” said Rafael Amado, M.D., executive vice president of research and development and chief medical officer at Allogene.

Allogene’s “off-the-shelf” allogeneic cellular treatments for cancer are intended to be readily available cell therapies for many patients. The treatments are more convenient alternatives to the highly personalized CAR-T therapies used to treat some blood cancers. The company is using its technology to develop treatments for lymphoma, leukemia, multiple myeloma and some solid tumors.

Allogene’s revolutionary therapies, if successful, could be pivotal for cancer treatment in the future.