NCT05464329

Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

A Phase Ib Study With Expansion Cohorts Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib independently.

Conditions

• Large B-cell Lymphoma
• High-grade B-cell Lymphoma
• Transformed B-Cell Lymphoma
• Follicular Lymphoma Grade 3B

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Provided by Genentech.
DRUG	DHAX	-Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.
DRUG	ICE	-Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.

Timeline

• Start date: 2023-01-03
• Primary completion: 2026-01-02
• Completion: 2029-10-16
• First posted: 2022-07-19
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study