eligibility_summary
Include: ≥18, WHO MCL with measurable disease, prior BTKi (progress/relapse or no PR by 12 wks), ECOG 0–2, adequate organs/coagulation (CrCl ≥30), contraception/negative pregnancy. Exclude: recent allo/auto SCT or CAR‑T, CNS MCL, prior pirtobrutinib or CD20xCD3‑refractory, recent stroke/ICH, live vaccine or major surgery, significant cardiac/QTcF>470, HIV or active HBV/HCV/CMV, pregnancy/lactation, malabsorption, uncontrolled infection/illness/AI cytopenias, strong CYP3A4/P‑gp drugs, warfarin.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05833763 tests a combination immunotherapy/targeted regimen in relapsed/refractory mantle cell lymphoma after prior BTK inhibitor: 1) Pirtobrutinib (LOXO-305): oral, small‑molecule, highly selective, reversible BTK inhibitor, blocks B‑cell receptor (BCR) signaling to suppress survival/proliferation of malignant B cells. 2) Glofitamab: IV CD20×CD3 bispecific antibody, engages CD3 on T cells and CD20 on B cells to redirect T‑cell cytotoxicity against CD20+ MCL, step‑up dosing to reduce cytokine release syndrome (CRS). Pre‑phase: Obinutuzumab, IV type II anti‑CD20 mAb, depletes B cells and mitigates CRS. Supportive: Tocilizumab, IV anti‑IL‑6 receptor mAb, for CRS management. Targets/pathways: CD20+ mantle B cells, T‑cell activation via CD3, BTK/BCR signaling in B cells, and IL‑6 inflammatory signaling. The study evaluates additive/synergistic activity and MRD‑negative remission rates.