Allogene Cleared to Resume Allogeneic CAR T-Cell Therapy Trials

Allogene Therapeutics has been cleared by the U.S. Food and Drug Administration (FDA) to resume trials of its allogeneic chimeric antigen receptor (CAR) T-cell therapies following an investigation into a chromosomal abnormality reported in a patient with pretreated stage IV follicular lymphoma who received the investigational ALLO-501A as part of the ALPHA2 study.

On October 7, 2021, the FDA placed a clinical hold on 5 clinical trials evaluating Allogene’s cell therapies. Investigators concluded that the chromosomal abnormality was not treatment-related and did not result in any health issues. In addition, the abnormality was not detected in any of Allogene’s products or in any other patient treated with ALLO-501A, according to a company press release.

Allogene’s treatments for lymphoma, leukemia, multiple myeloma, and certain solid tumors use allogeneic CAR T cells derived from induced pluripotent stem cells from healthy donors. The cells are then genetically modified using a gene-editing technique known as transcription activator–like effector nucleases (TALEN). The Company announced its plans to initiate the pivotal phase II trial of ALLO-501A in relapsed/refractory large B-cell lymphoma in mid-2022.

Source: Allogene Therapeutics press release, January 10, 2022.