eligibility_summary
Eligibility: Adults 18–70 with confirmed R/R DLBCL after ≥2 systemic lines, measurable disease, ECOG 0–1, life expectancy >3 mo, no prior transplant, adequate heart (EF≥50%), liver (AST/ALT≤2×ULN, bili<2×ULN), kidney (CrCl≥80), lung (SpO2>90%, PFTs≥50%), marrow reserve, consent/contraception. Exclude: prior auto-HSCT, HIV/HBV/HCV, uncontrolled infection, severe organ dysfunction (>3×ULN), heart disease (NYHA≥2), other cancers, VTE, pregnancy/lactation, severe immunosuppression, psych illness/noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests a Glofitamab-bridging-to-ASCT strategy in R/R DLBCL. Interventions and mechanisms: 1) Glofitamab (IV, step-up dosing): a CD20×CD3 bispecific T‑cell–engaging antibody (biologic). It binds CD20 on malignant B cells and CD3 on T cells, redirecting T cells to kill B cells via immune synapse formation, T‑cell activation, and cytotoxicity. 2) “Ottuzumab” (anti‑CD20 monoclonal antibody, biologic) given prior to Glofitamab to debulk and mitigate CRS, type II anti‑CD20 activity via direct cell death and Fc‑mediated ADCC/ADCP against CD20+ B cells. 3) ASCT with SEAM conditioning chemotherapy: simustine (nitrosourea alkylating agent, DNA crosslinks), etoposide (topoisomerase II inhibitor, DNA breaks), cytarabine (antimetabolite, DNA polymerase inhibition), plus protocol day‑6 agent. Targets/pathways: CD20+ B cells, CD3 on T cells, Fcγ‑effector pathways (NK/macrophages), and DNA replication/repair via cytotoxic chemotherapy.