eligibility_summary
Inclusion: Adults ≥18 with untreated, confirmed EMZL (I–IV), measurable disease or allowed skin/gastric/conjunctival criteria, biopsy, indication to treat, ECOG 0–2, adequate labs, life expectancy >3 mo, contraception. Exclusion: Transformation/DLBCL, CNS lymphoma (except dural), urgent cytoreduction, prior systemic therapy, active serious infection/immunosuppression, prior SCT/CAR‑T/transplant, recent malignancy, severe mAb/CHO/drug allergy, major autoimmune, significant cardiac/pulmonary disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial in untreated stage I–IV extranodal marginal zone lymphoma (EMZL) testing mosunetuzumab (Lunsumio, mosunetuzumab-axgb). Intervention: Mosunetuzumab is a subcutaneous, full-length humanized bispecific IgG1 antibody (T-cell–redirecting biologic) that binds CD20 on B cells and CD3 on T cells. Mechanism: It brings T cells into contact with malignant B cells, triggering TCR/CD3 activation, immune synapse formation, cytokine release, and perforin/granzyme-mediated cytotoxicity, depleting CD20+ malignant (and normal) B cells. Dosing: step-up SC dosing (5 mg C1D1, 45 mg C1D8 and C1D15, then 45 mg on Day 1 of Cycles 2–8, 21-day cycles). Targets: CD20+ EMZL B cells, T-cell receptor/CD3 signaling pathways driving cytotoxic T-cell killing. Purpose: assess efficacy and safety as first-line therapy.