Cellectis Reports Interim Data from Cema-Cel Pivotal Trial

Cellectis, a clinical-stage biotechnology company, has shared interim data from Allogene Therapeutics' pivotal ALPHA3 trial concerning cema-cel. The study evaluates cema-cel, an allogeneic CAR-T cell therapy candidate, as a first-line consolidation treatment for large B-cell lymphoma (LBCL).

The futility analysis revealed that 58.3% of patients in the cema-cel arm achieved minimal residual disease (MRD) negativity compared to 16.7% in the observation arm. This 41.6 absolute percentage point difference is considered significant, potentially translating to meaningful clinical benefit.

According to Allogene, cema-cel was generally well-tolerated, with most patients managed in an outpatient setting. No cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD) were reported. Treatment-related serious adverse events and hospitalizations were also absent among the evaluated patients.

"Seeing cema-cel advance in a pivotal trial is a great moment. Cema-cel derives from the first allogeneic CAR-T ever made, as Cellectis has pioneered the concept of allogeneic 'off-the-shelf' cell therapy," stated André Choulika, CEO of Cellectis. He added that the company believes its allogeneic platform will eventually replace autologous CAR-T therapies.

Allogene anticipates completing study accrual by the end of 2027, with potential Biologics License Application (BLA) submission following positive interim and primary analyses. Cellectis is eligible to receive up to $340 million in development and sales milestones, plus royalties, under its agreement with Servier.