Allogene Therapeutics Moves Forward with Standard Fludarabine and Cyclophosphamide (FC) Lymphodepletion Regimen in the ALPHA3 Trial for Cemacabtagene Ansegedleucel (Cema-Cel) in First-Line Consolidation for Large B-Cell Lymphoma

Core Insights - Allogene Therapeutics has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen for its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL) [1][6] - The trial's design has shifted to a randomized study comparing cema-cel after standard FC lymphodepletion to observation, with a futility analysis expected in the first half of 2026 [4][6] Company Developments - The arm testing FC plus ALLO-647 has been closed due to a Grade 5 adverse event attributed to ALLO-647, leading to a strategic shift in the company's clinical approach [2][3] - Allogene is advancing next-generation AlloCAR T product candidates using the proprietary Dagger Platform Technology, which aims to minimize or eliminate the need for standard lymphodepletion [3][6] Clinical Trial Information - The ALPHA3 trial is now a two-arm randomized study, with over 50 clinical sites activated across the U.S. and Canada [4][6] - The pivotal Phase 2 ALPHA3 study launched in June 2024 aims to treat LBCL patients who may relapse after first-line treatment [7][8] Market Context - Approximately 60,000 patients are expected to be treated for LBCL annually in the U.S., EU, and UK, with about 30% of those initially responding to treatment likely to relapse [8]