Summary
This is a randomized, open-label study in adult patients who have completed standard first line of 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 CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. 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.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.
Official Title
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
Keywords
Large B-cell Lymphoma, Diffuse large B-cell lymphoma, DLBCL, Primary mediastinal B-cell lymphoma, LBCL, High grade B-cell lymphoma, HGBCL, Double-hit lymphoma, High-risk lymphoma, Minimal Residual Disease, MRD, CAR T, Allogeneic CAR T, CD19, cema-cel, cemacabtagene ansegedleucel, ALLO-647, PMBCL, Consolidation, First-line, Front-line, Frontline, PhasED-Seq™, CLARITY™, Anti-CD52, AlloCAR T™, Lymphoma, B-Cell Lymphoma, Cyclophosphamide, Fludarabine, Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, cemacabtagene ansegedleucel, ALLO-647