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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
GlobeNewswire News Room· 2025-08-01 12:30
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 ALPHA3 trial has shifted to a randomized study design 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 decision to close the arm testing FC plus ALLO-647 was made due to a Grade 5 adverse event attributed to ALLO-647, leading to a review of trial data and a shift in clinical strategy [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 Details - The ALPHA3 study is designed to treat over 60,000 patients annually for LBCL in the US, EU, and UK, with cema-cel positioned as a potential standard "7th cycle" treatment following initial chemotherapy [8] - The trial has over 50 clinical sites activated across the US and Canada, including community cancer centers and major academic institutions [4][6] Product Information - Cemacabtagene ansegedleucel (cema-cel) is an investigational anti-CD19 AlloCAR T™ product for LBCL, with oncology rights held by Allogene in the US, EU, and UK, and options for rights in China and Japan [7][9]