Trials In Focus: Allogene Off-The-Shelf Study Mirrors Earlier CAR-T Trials

Allogene Therapeutics Inc. drew praise from analysts with the initiation of what it called the first potentially pivotal Phase II trial of an off-the-shelf CAR-T therapy, its CD19-targeted ALLO-501A, in patients with relapsed/refractory large B-cell lymphoma (LBCL). Analysts pointed to a trial design that largely mirrors past studies of autologous CAR-T therapies for what could become the first allogeneic CAR-T to win US Food and Drug Administration approval, which allows for better comparison between ALLO-501A and its autologous counterparts, particularly Gilead Sciences, Inc.’s Yescarta (axicabtagene ciloleucel).

The company announced the initiation of the single-arm, 100-patient ALPHA2 trial on 6 October, in which patients will receive the allogeneic ALLO-501A following a lymphodepletion regimen comprising fludarabine, cyclophosphamide and Allogene’s in-house anti-CD52 monoclonal antibody, ALLO-647