RecruitingPhase 2NCT05994235

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

A Phase II Trial of Tazemetostat Plus Mosunetuzumab in Untreated Follicular Lymphoma

Sponsor

Weill Medical College of Cornell University

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — tazemetostat (a targeted therapy) and mosunetuzumab (an immunotherapy that helps the immune system attack cancer cells) — as a first treatment for people with follicular lymphoma (a slow-growing type of blood cancer). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with follicular lymphoma (grade 1 to 3a) confirmed by a biopsy - You have not received any prior treatment for this lymphoma - Your cancer is measurable on a scan - You are in reasonably good health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have previously received treatment for follicular lymphoma - Your lymphoma is grade 3b or has transformed to a more aggressive type - You are in poor health that would prevent you from tolerating treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

Mosunetuzumab will be administered in weekly dose increments ("step-up dosing") during Cycle 1 and then on Day 1 of each cycle. Mosunetuzumab will be given in 28-day cycles for up to 12 cycles. Mosunetuzumab will be administered SC at the dose of 5 mg on Day 1, 45 mg on Day 8, and 45 mg on Day 15 in Cycle 1. Beginning with Cycle 2, it will be administered SC at the dose of 45 mg on Day 1. Each cycle lasts 4 weeks.

DRUGTazemetostat Pill

Oral tazemetostat will be administered by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation until disease progression, unacceptable toxicity, or consent is withdrawn. Patients will remain on tazemetostat for up to twelve 28-day cycles from initiation of mosunetuzumab.