eligibility_summary
Include: Adults ≥18, ECOG 0–2, life expectancy ≥12 wks, CD20+ MZL (splenic/nodal/extranodal) per WHO2008, stage III/IV or recurrent I/II, BTKi ≥6 mo allowed, measurable disease, NCCN treatment indication, no prior systemic MZL therapy (anti-HP/HCV allowed), adequate organ function, consent and contraception. Exclude: CNS disease, other active cancers, major cardiac/coagulation disorders, recent thrombosis or surgery, malabsorption, active infection incl HBV/HCV, psych/drug abuse, recent trial, strong CYP3A4 use, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in untreated marginal zone lymphoma (MZL) testing Orelabrutinib plus Zuberitamab. Orelabrutinib: an oral, selective covalent small-molecule Brutons tyrosine kinase (BTK) inhibitor that blocks B‑cell receptor (BCR) signaling, suppressing downstream pathways (e.g., NF‑κB/PI3K‑AKT/PLCγ2) to inhibit malignant B‑cell proliferation and survival. Zuberitamab: an anti‑CD20 monoclonal antibody that binds CD20 on B lymphocytes, depleting B cells via antibody‑dependent and complement‑dependent cytotoxicity and apoptosis. Targets: CD20‑positive B cells and the BTK node of the BCR pathway. Regimen: 12×28‑day cycles, Orelabrutinib daily, Zuberitamab 375 mg/m2 IV D1 for cycles 1–6, then every 2 cycles (7–12). Primary endpoint: complete response rate.