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Clinical Trials | 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 (ALPHA3)

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 (ALPHA3)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with large B-cell lymphoma who have just completed initial therapy. The purpose of this study is to see if CAR T cells made from healthy donors are an effective treatment to prevent relapse in participants who have lymphoma DNA detected in their blood by an investigational test at the end of initial therapy. For reference, CAR T cells are T cells (a type of immune system white blood cell) that have been engineered to attack cancer cells, like lymphoma. In this study, you will be randomly assigned (like the flip of a coin) to either continued observation (the current standard of care) without any investigational drug treatment, or to receive treatment with the investigational study product cemacabtagene ansegedleucel (cema-cel) with or without ALLO-647, an investigational study product which may help prepare the body for receiving cema-cel. You cannot choose what group you will be assigned to. However, you and the study doctor and staff will know if you are receiving ALLO-647 and/or cema-cel. If you are assigned to receive treatment, you will be treated shortly after enrolling into the study. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. After enrollment, your health will be closely monitored for 60 months (5 years) regardless of which study group (treatment or observation) you are assigned to. This is the follow-up period. You will be asked to return to the study center for regular visits during which specific tests and procedures will be performed. Additional information found here: https://clinicaltrials.gov/study/NCT05714345 For questions, contact: [email protected]