eligibility_summary
Adults (≥18) with MCL plus ≥1 high‑risk feature (blastoid/pleomorphic, Ki‑67≥30%, TP53/del17p, complex karyotype, MIPI≥6.2, progression <24 mo, or mutations KMT2D/NSD2/NOTCH1/NOTCH2/CDKN2A/SMARCA4/CCND1), ECOG 0–2, life expectancy ≥12 wks, measurable disease, adequate counts (lower thresholds if marrow involvement) CrCl≥30. Exclude: study‑drug contraindications, active infection, HBV/HCV viremia, other malignancy, active autoimmune disease, CNS lymphoma, or other serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06656221: Phase 2, single-arm trial in high-risk mantle cell lymphoma testing glofitamab + orelabrutinib + bortezomib with obinutuzumab lead-in. Drugs/MOAs: • Glofitamab (bispecific antibody, CD20xCD3 T‑cell engager) redirects CD3+ T cells to kill CD20+ malignant B cells. • Obinutuzumab (type II, glycoengineered anti‑CD20 monoclonal antibody) depletes CD20+ B cells via enhanced ADCC and direct cell death, used as pre‑treatment to mitigate CRS. • Orelabrutinib (oral, covalent BTK inhibitor) blocks B‑cell receptor signaling to reduce proliferation/survival. • Bortezomib (26S proteasome inhibitor) suppresses NF‑κB activation and induces apoptosis. Targets/pathways: CD20 on MCL B cells, CD3 on T cells, BTK within BCR signaling, proteasome/NF‑κB axis, T‑cell–mediated cytotoxicity against malignant B cells.