eligibility_summary
Adults 18–80, ECOG ≤2, untreated mantle cell lymphoma needing therapy, confirmed by IHC/flow with t(11,14)/cyclin D1 or SOX11, must have high‑risk features (e.g., blastoid, Ki67≥50%, TP53/del17p). Adequate blood counts/organ function, oral intake, consent/tissue, contraception/REMS. Exclude: warfarin, strong CYP3A drugs/grapefruit, high‑dose steroids, live vaccine/recent major surgery, active HBV/HCV/HIV/TB/infections, major CV/CNS/autoimmune disease, pregnancy, malabsorption.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II single-arm trial in newly diagnosed high‑risk mantle cell lymphoma testing: 1) Glofitamab, a CD20×CD3 bispecific monoclonal antibody (T‑cell engager) that redirects patient T cells via CD3 to kill CD20+ malignant B cells. 2) Obinutuzumab, a type II anti‑CD20 monoclonal antibody that depletes B cells and enhances ADCC, used as pretreatment to reduce tumor burden/CRS risk. 3) Venetoclax, an oral small‑molecule BCL‑2 inhibitor that induces mitochondrial (intrinsic) apoptosis in BCL‑2–dependent lymphoma cells. 4) Lenalidomide, an oral immunomodulatory drug (IMiD) that binds cereblon to degrade IKZF1/3, boosts T‑ and NK‑cell activity, and has anti‑angiogenic effects. Targeted cells/pathways: CD20+ B‑cell lymphoma cells, T cells via CD3 engagement, BCL‑2 anti‑apoptotic pathway, cereblon–IKZF1/3 axis and Fc‑mediated ADCC. Aim: deepen responses and improve PFS/MRD negativity, including in TP53‑aberrant disease.