Cellectis Announces Positive Interim Data from Pivotal ALPHA3 Trial of Cema-cel in LBCL

2026-04-13SEC Filing 6-K (0001171843-26-002410)

On April 13, 2026, Cellectis announced positive interim futility analysis data from the pivotal ALPHA3 trial of cema-cel, an allogeneic CAR-T therapy licensed to Servier and sublicensed to Allogene Therapeutics. The trial is evaluating cema-cel as a first-line consolidation treatment for large B-cell lymphoma (LBCL). Results from the first 24 patients showed that 58.3% (7/12) in the cema-cel arm achieved minimal residual disease (MRD) negativity, compared to only 16.7% (2/12) in the observation arm, representing a 41.6% absolute difference. Cema-cel was well-tolerated with no cases of CRS, ICANS, or GvHD reported at the cutoff. Most patients were managed in an outpatient setting. Under its agreement with Servier, Cellectis is eligible for up to $340 million in milestones plus royalties on net sales. Allogene expects to complete trial accrual by the end of 2027, with interim event-free survival (EFS) data anticipated in mid-2027 and primary EFS data in mid-2028, which could support a BLA submission.

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