OncoMatch/Clinical Trials/NCT05994235
Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma
Is NCT05994235 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mosunetuzumab and Tazemetostat Pill for follicular lymphoma.
Treatment: Mosunetuzumab · Tazemetostat Pill — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: EZH2 mutation testing required
Availability of a representative tumor specimen and the corresponding pathology report at the time of diagnosis for confirmation of the diagnosis of FL and for EZH2 mutation testing.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: local radiotherapy is not considered systemic therapy
Received no prior systemic lymphoma therapy (local radiotherapy is not considered systemic therapy)
Cannot have received: systemic immunosuppressive medications (prednisone, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents)
Exception: inhaled corticosteroids, mineralocorticoids for orthostatic hypotension, dexamethasone for nausea/B symptoms/bulky disease (max 40 mg x5 days or equivalent) permitted
Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant (SCT)
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL; ANC ≥1.0 x 10/L; Platelet count ≥75x10/L
Kidney function
Measured or estimated creatinine clearance ≥30 mL/min by institutional standard method
Liver function
AST or ALT ≤ 2.5 x ULN; Serum total bilirubin ≤1.5xULN (or ≤3 x ULN for patients with Gilbert syndrome)
Adequate hematologic function defined as follows: Hemoglobin ≥ 8.0 g/dL; ANC ≥1.0 x 10/L; Platelet count ≥75x10/L. Adequate renal and hepatic function as defined as follows: Measured or estimated creatinine clearance ≥30 mL/min by institutional standard method; AST or ALT ≤ 2.5 x ULN; Serum total bilirubin ≤1.5xULN (or ≤3 x ULN for patients with Gilbert syndrome)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Weill Cornell Medicine/NewYork-Presbyterian Hospital · New York, New York
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