eligibility_summary
Include: R/R MCL with cyclin D1 overexpression or t(11,14), ≥1 prior systemic line incl BTKi, measurable disease, tissue available, ECOG 0–2, HIV−, adequate counts, life expectancy ≥12 wks. Exclude: pregnancy, leukemic non‑nodal MCL, severe mAb allergy, contra to anti‑CD20 and to bendamustine/lenalidomide, prior CD20xCD3 or CAR‑T, recent therapy, CNS lymphoma/other CNS disease, major CV disease, infections (incl TB), HBV/HCV, EBV, HLH/PML, unresolved ≥G2 AEs, live vaccine, transplant or SCT‑eligible, active autoimmune on treatment, recent immunosuppressants/steroids, recent major surgery, cirrhosis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III open-label study in relapsed/refractory mantle cell lymphoma compares glofitamab monotherapy (with obinutuzumab pretreatment) vs investigator’s choice: bendamustine+rituximab (BR) or rituximab+lenalidomide (R‑Len), tocilizumab allowed for CRS. Glofitamab: CD20×CD3 T‑cell–engaging bispecific IgG mAb that redirects T cells to lyse CD20+ B cells (T‑cell activation/cytokines). Obinutuzumab: type II anti‑CD20 mAb (ADCC/ADCP, direct cell death) used to deplete B cells/mitigate CRS. Rituximab: type I anti‑CD20 mAb (CDC/ADCC). Bendamustine: alkylating agent causing DNA cross‑links/apoptosis. Lenalidomide: IMiD that enhances T/NK activity and degrades IKZF1/3 via cereblon. Tocilizumab: IL‑6 receptor–blocking mAb for CRS. Targets/pathways: CD20+ malignant B cells, CD3 on T cells, NK‑cell ADCC, DNA damage response, cereblon‑IKZF1/3 axis, IL‑6 signaling.