NCT06563505

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary Objectives: To determine the safety and efficacy of mosunetuzumab in combination with zanubrutinib as determined by best complete response (CR) rate of combination treatment for patients with relapsed or refractory marginal zone lymphoma (MZL). Secondary Objectives: To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, progression-free survival (PFS), overall survival (OS), and evaluation of tolerability of mosunetuzumab and zanubrutinib as treatment for patients with relapsed/refractory MZL. Exploratory Objective: To determine the impact of total metabolic tumor volume to ORR, CR rate and survival outcomes To determine the biomarkers that correlates with response and mechanisms of resistance to mosunetuzumab and zanubrutinib in relapsed/refractory MZL. To determine the surrogate endpoint for future trials in MZL.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Given by IV
DRUG	Zanubrutinib	Given by IV

Timeline

• Start date: 2024-12-11
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-08-20
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study