Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
NCT05410418 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-12-15
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
- 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.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Institute for Follicular Lymphoma
collaborator UNKNOWN -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
David A Russler-Germain, M.D., Ph.D. · Washington University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-24
- Primary Completion
- 2025-09-18
- Completion
- 2029-04-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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