Cellectis Highlights Interim Data from Allogene's Cema-cel Pivotal Trial
Allogene Therapeutics announced interim futility analysis data from its ALPHA3 pivotal trial evaluating cema-cel for first-line treatment of large B-cell lymphoma. The analysis showed a significant MRD negativity rate.
Cellectis, a clinical-stage biotechnology company, has noted the interim futility analysis results from Allogene Therapeutics' sponsored ALPHA3 pivotal trial. The trial is evaluating cema-cel as a first-line consolidation treatment for large B-cell lymphoma (LBCL).
The interim analysis, based on MRD assessment at Day 45 for 24 patients, revealed that 58.3% of patients in the cema-cel arm achieved minimal residual disease (MRD) negativity. This compares to 16.7% in the observation arm, showing a 41.6% absolute difference in MRD clearance.
Cema-cel is an allogeneic CAR-T cell therapy derived from healthy donor T-cells, designed to overcome challenges associated with autologous therapies, such as speed, accessibility, and product consistency.
Allogene reported that the treatment was generally well-tolerated, with no cases of cytokine release syndrome (CRS) or neurotoxicity (ICANS) reported. Patient enrollment is expected to complete by the end of 2027, with positive results potentially supporting a future Biologics License Application (BLA) submission.