Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma

Recruiting now · Phase 2

Conditions studied: Follicular Lymphoma

In brief

The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). The study plans to enroll approximately 80 patients, who will be assigned to three distinct cohorts: previously untreated high-risk FL (Cohort 1), previously untreated low-tumor-burden FL (Cohort 2), and relapsed or refractory FL (Cohort 3). The study consists of a safety run-in phase, which will be initially conducted in Cohort 1 to assess the tolerability of the combination therapy, followed by an expansion phase across all three cohorts to further evaluate the clinical outcomes.

Key facts

Study ID: NCT07555470
Run by: Institute of Hematology & Blood Diseases Hospital, China
People needed: 80
Starts: 2026-04-10
Expected to finish: 2029-12-31
Last updated by the study team: 2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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：
Histologically confirmed Grade 1-3a follicular lymphoma (FL), CD20-positive, with no evidence of histologic transformation
Ann Arbor Stage III/IV
No prior systemic therapy for FL
Meeting at least one of the GELF criteria for indicating treatment
FLIPI-1 or FLIPI-2 score of 3 to 5 (High risk)
Cohort 2- Previously Untreated Low-Tumor-Burden FL：
Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no prior systemic therapy.
Absence of B symptoms or severe pruritus
Low tumor burden (LTB) not meeting GELF criteria for treatment
Must have at least one measurable lesion (longest diameter >1.5 cm)
Patients who are suffering from the disease or prefer active management over a watch-and-wait approach
Cohort 3-Relapsed or Refractory FL：
Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no evidence of histologic transformation.、
Relapsed or refractory disease, having received at least 1 prior systemic therapy regimen containing an anti-CD20 antibody
No prior treatment with a CD20/CD3 bispecific antibody or an EZH2 inhibitor
Presence of at least one measurable or evaluable lesion at relapse

You may not qualify if…

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 is running

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Tianjin, China

Full record on ClinicalTrials.gov

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