A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITYâ„¢ Investigational Use Only (IUO) MRD test, powered by PhasED-Seqâ„¢. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.
Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
Key Inclusion Criteria:
Key Exclusion Criteria:
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Gilbert, Arizona 85234, United States
Sacramento, California 95817, United States
Washington D.C., District of Columbia 20007, United States
Chicago, Illinois 60611, United States
Louisville, Kentucky 40202, United States
Baltimore, Maryland 21201, United States
Columbia, Missouri 65212, United States
St Louis, Missouri 63110, United States
New York, New York 10032, United States
Toronto, Ontario M5G 1Z5, Canada
Montreal, Quebec H1T 2M4, Canada
Seogu, Busan South Korea, South Korea