eligibility_summary
Eligibility: Adults ≥18 with histologically confirmed LBCL (DLBCL, HGBCL, or PMBCL) who completed first-line R-CHOP/EPOCH-R/Pola-R-CHP, achieved CR or observation-suitable PR, and are MRD+ by CLARITY (PhasED-Seq), ECOG 0–1, adequate organ function, prior toxicities ≤grade 1. Excludes CNS-involved or transformed or T-cell/histiocyte–rich LBCL, prior anti-CD19 therapy, post-EOT treatment, active autoimmune/infection, or other malignancy/BM disorder within 3 yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19-directed CAR T-cell therapy, lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Before Aug 2025, some participants may also have received ALLO-647 (anti-CD52 monoclonal antibody). A CLARITY/PhasED-Seq MRD ctDNA test is used for selection/monitoring, the control arm is observation. Mechanisms/targets: Cema-cel uses donor T cells engineered with a CAR that binds CD19 on malignant and normal B cells, triggering T-cell activation and cytotoxic killing to eradicate minimal residual disease. Fludarabine/cyclophosphamide deplete host lymphocytes and impair DNA synthesis to enable CAR T expansion. ALLO-647 depletes CD52+ immune cells (T, B, NK), limiting rejection of allogeneic CAR T cells. Target: CD19+ B-cell lymphoma cells.