Mosunetuzumab + Lenalidomide for Follicular Lymphoma
Trial Summary
What is the purpose of this trial?
This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have taken certain immunosuppressive medications within 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drugs Mosunetuzumab and Lenalidomide for treating follicular lymphoma?
Lenalidomide, when combined with rituximab, has been shown to significantly extend the time patients live without their disease getting worse in follicular lymphoma, according to the AUGMENT trial. Mosunetuzumab, a new type of drug that helps the immune system target cancer cells, has been conditionally approved in the EU for patients with follicular lymphoma who have tried other treatments without success.12345
How is the drug combination of Mosunetuzumab and Lenalidomide unique for treating follicular lymphoma?
The combination of Mosunetuzumab and Lenalidomide is unique because Mosunetuzumab is a T-cell-engaging bispecific antibody that targets CD20 and CD3, offering a novel mechanism by redirecting T-cells to attack cancer cells, while Lenalidomide is an immunomodulatory drug that enhances the immune response. This combination provides a chemotherapy-free option that could be more effective for patients with relapsed or refractory follicular lymphoma.12346
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with follicular lymphoma who've had at least one prior treatment. They must be in stable condition, not have severe allergies to monoclonal antibodies or certain infections, and agree to contraception if of childbearing potential. Those with a history of certain other cancers or conditions are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mosunetuzumab plus lenalidomide for 12 cycles (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Maintenance
Participants with complete or partial metabolic response receive maintenance therapy with SC mosunetuzumab every 8 weeks for an additional 9 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lenalidomide (Immunomodulatory agents)
- Mosunetuzumab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University