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

Trial Design Draws Analyst Praise

 
• By Alaric DeArment

In Scrip’s new column tracking clinical trial developments, NewAmsterdam, CatalYm, Verve, Bellerophon and Almirall announced new trials or changes to existing ones, while CROs Parexel and PPD announced new programs and CTI appointed a new exec.

• Source: Shutterstock

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...

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