NCT05410418

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

A Phase II Study Evaluating the Efficacy of Mosunetuzumab in Combination With Polatuzumab Vedotin in Untreated Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial studies the combination of mosunetuzumab and polatuzumab vedotin in order to see how well it works in patients with untreated follicular lymphoma. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks like killing virus-infected cells, and cancerous B cells. Mosunetuzumab has been designed to direct these T cells to kill the cancerous B cells instead. Polatuzumab vedotin is an antibody-drug conjugate that attaches to certain cancerous B cells and then delivers a drug specifically to those cells.

Conditions

• Lymphoma, Follicular
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Mosunetuzumab is administered subcutaneously using a "step-up" dosing strategy. The initial dose on C1D1 will be 5 mg, and doses thereafter will be 45 mg.
DRUG	Polatuzumab vedotin	Polatuzumab vedotin is administered intravenously over 90 minutes for the initial dose, and over 30 minutes thereafter.

Timeline

• Start date: 2022-10-24
• Primary completion: 2025-09-18
• Completion: 2029-04-24
• First posted: 2022-06-08
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study