This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies. Prior exposure to 2 or less doses without evidence of resistance is allowed
Prior treatment with polatuzumab vedotin or with an antibody-drug conjugate containing monomethyl auristatin E (MMAE). Prior exposure to 2 or less doses without evidence of resistance is allowed
Allogeneic stem cell transplant within 2 years prior to day 1 of protocol therapy, requires immunosuppression, or has evidence of active-versus-host-disease
Patients who had an allogeneic transplant > 2 years prior to day 1 of protocol therapy must additionally have been stable off immunosuppressive agents for ≥ 2 months
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Mosunetuzumab
Biological/VaccineGiven SC
Polatuzumab Vedotin
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary Studies
Incidence of grade 3 or higher adverse events (AEs)
Unacceptable toxicity will be defined as events occurring during the first 2 cycles of treatment that is at least possibly related to study treatment. Observed toxicities will be summarized by type, severity, and attribution.
Complete response (CR) rate
CR rate will be defined as the proportion of response-evaluable participants that achieve a best response of CR after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. CR rate will be estimated along with the 95% exact binomial confidence interval.
Incidence of AEs
AEs will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Cytokine release syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Criteria. Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) will be graded according to the ASTCT ICANS Consensus Grading Criteria. Observed toxicities will be summarized by type, severity, and attribution.
Overall response rate (ORR)
ORR will be defined as the proportion of response-evaluable participants that achieve a best response of CR or partial response (PR) after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated along with the 95% exact binomial confidence interval.
Time to first CR
Time to first CR will be defined as the time from start of protocol therapy until the time the patients first achieve CR. Time for first CR will be summarized by descriptive statistics.
Time to best response
Time to best response will be defined as the time from start of protocol therapy until the time the patients achieve first best response (CR or PR). Time to best response will be summarized by descriptive statistics.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
