Mosunetuzumab and Zeprumetostat in Follicular Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, Phase 2, open-label study evaluating the combination of Mosunetuzumab with the EZH2 inhibitor Zeprumetostat (SHR2554) in follicular lymphoma. It includes a safety run-in in previously untreated high-risk FL, followed by expansion across three cohorts: previously untreated high-risk FL, previously untreated low-tumor-burden FL, and relapsed or refractory FL. Approximately 80 participants will be enrolled to assess efficacy and safety across cohorts, with stagewise introduction of the combination therapy. The trial will monitor dose-limiting toxicities during the initial cycle and collect clinical outcomes to determine tolerability and potential benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematologic and organ function
* Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use highly effective contraception; male subjects must agree to use effective contraception.
* Voluntary written informed consent
* Cohort 1- Previously Untreated High-Risk FL：

  1. Histologically confirmed Grade 1-3a follicular lymphoma (FL), CD20-positive, with no evidence of histologic transformation
  2. Ann Arbor Stage III/IV
  3. No prior systemic therapy for FL
  4. Meeting at least one of the GELF criteria for indicating treatment
  5. FLIPI-1 or FLIPI-2 score of 3 to 5 (High risk)
* Cohort 2- Previously Untreated Low-Tumor-Burden FL：

  1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no prior systemic therapy.
  2. Absence of B symptoms or severe pruritus
  3. Low tumor burden (LTB) not meeting GELF criteria for treatment
  4. Must have at least one measurable lesion (longest diameter \>1.5 cm)
  5. Patients who are suffering from the disease or prefer active management over a watch-and-wait approach
* Cohort 3-Relapsed or Refractory FL：

  1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no evidence of histologic transformation.、
  2. Relapsed or refractory disease, having received at least 1 prior systemic therapy regimen containing an anti-CD20 antibody
  3. No prior treatment with a CD20/CD3 bispecific antibody or an EZH2 inhibitor
  4. Presence of at least one measurable or evaluable lesion at relapse

Exclusion Criteria:

* Central nervous system (CNS) lymphoma, primary mediastinal lymphoma, or evidence of histologic transformation.
* Uncontrolled cardiovascular, cerebrovascular, coagulopathy, connective tissue, or severe infectious diseases.
* Pregnant or lactating women.
* Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) infection (RNA PCR positive).
* Concurrent other malignancies or history of malignancies, or anti-cancer therapy (including major surgery) within the last 4 weeks.
* Allergic reaction to the study drugs.
* Concurrent use of strong CYP3A4 inhibitors or strong CYP3A4 inducers that cannot be avoided
* Other medical or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.

Where it's running

• Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting
• Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
  Tianjin, China Not yet recruiting

Study contacts

• Study coordinator: Shuhua Yi, Dr
• Email: yishuhua@ihcams.ac.cn
• Phone: +86-022-23909106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether subcutaneous mosunetuzumab can be safely and effectively used as initial treatment for adults with newly diagnosed follicular lymphoma with low tumor burden.

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• Treatment with Mosunetuzumab for newly diagnosed Follicular Lymphoma

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• First-line treatment for follicular and marginal zone lymphoma using mosunetuzumab and lenalidomide

  This study is testing if a new combination of treatments can help adults with untreated follicular or marginal zone lymphoma feel better and improve their response to therapy.

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• MK-1045 and Rituximab in Follicular Lymphoma

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• Mosunetuzumab for people with systemic lupus erythematosus

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.