"The trial, which initiated in June 2024, now has 40 sites activated and continues to generate strong enthusiasm from both community cancer centers and academic institutions."
"This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). The lymphodepletion selection and futility analysis are anticipated around mid-2025. Efficacy analyses from the ALPHA3 trial are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis around YE 2026. A potential biologics license application (BLA) submission is targeted for 2027."
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