NCT07555470 Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma
| NCT ID | NCT07555470 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-04-10 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07555470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07555470 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07555470 currently recruiting?
Yes, NCT07555470 is actively recruiting participants. Contact the research team at yishuhua@ihcams.ac.cn for enrollment information.
Where is the NCT07555470 trial being conducted?
This trial is being conducted at Tianjin, China, Tianjin, China.
Who is sponsoring the NCT07555470 clinical trial?
NCT07555470 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 80 participants.