Cemacabtagene ansegedleucel (cema-cel) (ALPHA3)

July 29, 2026: Allogene Therapeutics, Inc. (NASDAQ: ALLO) said the FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for adult patients with large B-cell lymphoma (LBCL) who, after completing first-line therapy, are in complete or partial response suitable for observation but are minimal residual disease (MRD)-positive. The designations were based on a full FDA review of an interim protocol-defined futility analysis from the ongoing pivotal Phase 2 ALPHA3 trial.

ALPHA3 enrolls MRD-positive patients identified using Natera’s CLARITY MRD assay and randomizes them to single-dose cema-cel vs close observation. At the Day 45 MRD assessment data cutoff (triggered when the 24th patient completed Day 45), 58.3% (7/12) of cema-cel patients achieved MRD negativity vs 16.7% (2/12) on observation (41.6% absolute difference). The release also reports a 97.7% median decrease in plasma ctDNA at Day 45 with cema-cel vs a 26.6% median increase in the observation arm.

Safety at cutoff: no treatment-related serious AEs; no CRS, ICANS, GvHD, or high-grade infections; no tocilizumab/steroids; no hospitalizations for treatment-related AEs, with most patients managed outpatient.