Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT06015880 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-13
Summary
This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.
Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- High Grade B-Cell Lymphoma
- Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Computed Tomography
Undergo PET/CT
- DRUG
-
Given PO
- BIOLOGICAL
-
Mosunetuzumab
Given IV
- DRUG
-
Polatuzumab Vedotin
Given IV
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Joseph M Tuscano · City of Hope Comprehensive Cancer Center LAO
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-20
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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