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FDA lifts clinical hold on allogeneic CAR T cell therapy trials

Jan 13, 2022

On January 10, 2022, the U.S. Food and Drug Administration (FDA) lifted the clinical hold across all trials investigating allogeneic chimeric antigen receptor (allo-CAR) T-cell therapies.1 The clinical hold was introduced in October 2021 after it was reported that one patient with pretreated stage IV follicular lymphoma showed evidence of a chromosomal abnormality after receiving ALLO-501A CAR T cells in the phase I/II ALPHA2 study (NCT04416984). However, investigators confirmed that this was unrelated to any alloCAR-T product or the manufacturing process and had no clinical significance. The abnormality was an isolated event and was not detected in any other patient treated with the same ALLO-501A lot.

Clinical trials within the alloCAR-T platform are due to resume with the phase II trial of ALLO-501A in relapsed/refractory large B-cell lymphoma, it is expected to commence in mid-year 2022 pending discussions with the FDA. The clinical hold affected five alloCAR T trials designed to treat non-Hodgkin lymphoma and R/R multiple myeloma.

About allo-CAR T-cells

Allo-CAR T cells are derived from induced pluripotent stem cells from healthy donors that are genetically modified using the transcription activator-like effector nucleases (TALEN) gene-editing technology.

  1. Allogene Therapeutics. Allogene Therapeutics announces removal of FDA clinical hold across all AlloCAR T™ clinical trials. Published January 10, 2022. Accessed January 12, 2022.