eligibility_summary
Adults (≥18) with untreated mantle cell lymphoma, ECOG ≤2, contraception, adequate labs: ANC≥1.0×10^9/L, platelets≥75k (≥50k if BM+), PT/aPTT≤1.5×ULN, Cr≤2×ULN & CrCl≥50, AST/ALT≤3×ULN, bili≤1.5×ULN (Gilbert ok). Exclude CNS MCL, recent other cancers, CYP3A4 inhibitors/inducers, recent SCT/CAR‑T or major surgery, major CVD (MI/angina/CHF III–IV/arrhythmias/QTcF>480/HTN), prior BCL2/BTK, active HBV/HCV/HIV, GI malabsorption, pregnancy/lactation, recent stroke/ICH.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, single-arm trial in untreated mantle cell lymphoma testing a chemo-free triplet: sonrotoclax (BGB-11417), zanubrutinib (BGB-3111), and an anti-CD20 monoclonal antibody (recommended rituximab). Sonrotoclax is an oral small-molecule, selective BCL-2 inhibitor (BH3 mimetic) that induces mitochondrial apoptosis in lymphoma cells. Zanubrutinib is an oral covalent Bruton’s tyrosine kinase (BTK) inhibitor that blocks B-cell receptor signaling (e.g., NF-κB/PI3K–AKT), reducing survival and trafficking of malignant B cells. Anti-CD20 mAb binds CD20 on B cells, mediating ADCC, CDC, and direct apoptosis. Targets: CD20+ mantle cell lymphoma B cells, BCL-2–mediated anti-apoptotic pathway, BTK-dependent BCR signaling. Conducted in China.