eligibility_summary
Inclusion: Adults (≥18) with biopsy‑confirmed CD20+ MZL (MALT/SMZL/NMZL) that progressed/relapsed or is unsuitable after local therapy, ECOG 0–2, adequate labs (CBC/chemistry/coagulation), life expectancy ≥3 months, consent. Exclusion: other malignancy unless cured and disease‑free ≥5y, CNS lymphoma/transform, major cardiac disease (CHF/MI/arrhythmia/cardiomyopathy/QTc), uncontrolled HTN, recent bleeding/anticoagulants, active HBV/HCV/HIV or serious infection, otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in untreated, CD20+ marginal zone lymphoma (MALT, nodal, splenic) testing OG: orelabrutinib (150 mg QD, covalent, highly selective small-molecule Bruton’s tyrosine kinase [BTK] inhibitor) plus obinutuzumab (glycoengineered type II anti-CD20 IgG1 monoclonal antibody). Orelabrutinib blocks B-cell receptor signaling via BTK, inhibiting downstream NF-kB and PI3K-AKT pathways to reduce B-cell proliferation/survival. Obinutuzumab binds CD20 on B cells to drive direct cell death and enhanced immune effector killing (ADCC/ADCP, some CDC). Targets: CD20+ malignant B cells, BCR/BTK signaling and immune-mediated cytotoxic clearance. Regimen: 6 cycles OG, responders get 18 cycles orelabrutinib. Primary endpoint: 12-month CR rate.