Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT05994235
Brief Summary:
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.
Detailed Description:
This is a phase II, open-label study. Fifty patients will be enrolled and treated with standard dosing of SC mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation. Response assessments by PET/CT will occur post-mosunetuzumab at Cycle 4, Day 1 (+/- 3 days) and again at the end of treatment. If a participant has a complete response (CR) at Cycle 4 and/or cycle 8, then they will receive a total of 8 cycles of mosunetuzumab. If the patient has a partial response or stable disease at Cycle 4 and Cycle 8, then they will receive a total of 12 cycles of mosunetuzumab. All participants will receive 12 cycles of tazemetostat, unless discontinued from treatment early for disease progression or other protocol-defined reasons. Treatment with steroids, tocilizumab, growth factors, tumor lysis prophylaxis, and antibiotics may be used as per standard of care at our institution. Dose modifications are permitted for toxicity. Correlative studies will be performed prior to and following tazemetostat treatment and peripheral blood collections prior to post-mosunetuzumab treatment, which will give additional descriptive data for use in correlative analyses.
Study:
NCT05994235
Study Brief:
Protocol Section:
NCT05994235