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Recruiting Phase 2 NCT06563505

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

Trial Parameters

Condition Lymphoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-11
Completion 2026-12-31
Interventions
MosunetuzumabZanubrutinib

Brief Summary

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Eligibility Criteria

Inclusion Criteria: Patients must meet the following criteria for study entry: 1. Histologically diagnosed marginal zone lymphoma (any subtypes) o Low grade or indolent B-cell lymphoma unclassifiable is also eligible 2. Have received at least 1 prior treatment including CD20 monoclonal antibody 3. Patients have relapsed or refractory disease to their most recent regimen 4. Stage II, III or IV disease 5. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of mosunetuzumab and zanubrutinib combination in patients \<18 years of age, children are excluded from this study. 6. Performance status ≤2 on the ECOG scale (≤3 if due to lymphoma) 7. Requiring systemic therapy assessed by investigator based on tumor size, symptoms and/or GELF criteria * A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter * At least 3 nodal or extranodal sites ≥ 3 cm in diameter * Presence of at least one B symptom * Fever (\>38 C), night sweats, weight los

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