A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of mosunetuzumab + polatuzumab vedotin + lenalidomide in relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL). SECONDARY OBJECTIVE: I. To observe and record anti-tumor activity of the combination of mosunetuzumab, polatuzumab vedotin, and lenalidomide in R/R DLBCL. EXPLORATORY OBJECTIVES: I. To assess the efficacy in patients that have failed prior polatuzumab vedotin containing regimens (i.e., patients who progressed/relapsed after prior polatuzumab). II. To assess anti-tumor activity in patients that a) have ≥ De…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma as per the World Health Organization 2022 criteria * All patients will have relapsed/refractory DLBCL after 1 or more prior lines of therapy with the exception of patients receiving CAR T in second line that have a D score of 3 at day (D)+ 30 through D+ 90 * Patients who progressed/relapsed after prior polatuzumab vedotin are allowed * For the expansion cohorts only: cohort A must have Deauville score of ≥ 3 with the first 90 days) after standard of care ch…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo PET/CT
- DrugLenalidomide
Given PO
- BiologicalMosunetuzumab
Given IV
- DrugPolatuzumab Vedotin
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
Locations (8)
- City of Hope Comprehensive Cancer CenterDuarte, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- Moffitt Cancer CenterTampa, Florida
- Northwestern UniversityChicago, Illinois
- Wake Forest University Health SciencesWinston-Salem, North Carolina
- Case Western Reserve UniversityCleveland, Ohio