Tazemetostat + Mosunetuzumab for Follicular Lymphoma
Trial Summary
What is the purpose of this trial?
The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety. Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas. Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What makes the drug combination of Tazemetostat and Mosunetuzumab unique for treating follicular lymphoma?
This drug combination is unique because it combines Mosunetuzumab, a bispecific antibody that engages T-cells to target cancer cells, with Tazemetostat, an oral inhibitor that targets a specific mutation in some follicular lymphoma cases. This approach offers a novel mechanism by combining immunotherapy with targeted therapy, potentially improving outcomes for patients who have not responded to other treatments.12345
Research Team
Samuel Yamshon, M.D.
Principal Investigator
Weill Medical College of Cornell University
Eligibility Criteria
This trial is for adults with untreated follicular lymphoma (Grades 1-3a) who can follow the study plan and are willing to use effective birth control. People with a history of certain blood cancers, severe infections like Hepatitis B/C or HIV, significant heart or lung disease, recent major surgery, CNS diseases, pregnancy, organ transplants, allergic reactions to monoclonal antibodies or active autoimmune diseases cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous mosunetuzumab and oral tazemetostat in 28-day cycles for up to 12 cycles
Response Assessment
Response assessments by PET/CT at 12 weeks, 30 weeks, and 48 weeks for ongoing response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mosunetuzumab
- Tazemetostat
Mosunetuzumab is already approved in European Union, United States for the following indications:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Epizyme, Inc.
Industry Sponsor