Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma

NCT07555470 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2026013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• Best Complete Response (CR) Rate (Cohort 1 and Cohort 3)

  The best complete response (CR) rate is defined as the percentage of participants who achieve a complete response during the treatment period, as assessed by the investigator according to the Lugano 2014 classification criteria

  Up to approximately 12 months (From start of treatment until the end of up to 12 cycles of treatment)

• 3-Year Event-Free Survival (EFS) Rate (Cohort 2)

  Event-Free Survival (EFS) is defined as the time from the start of treatment to the first occurrence of any of the following events: progression to high-tumor-burden (HTB) based on GELF criteria, initiation of cytotoxic chemotherapy and/or radiotherapy, histologic transformation, or death from any cause.

  Up to 3 years

Secondary Outcomes (7)

• Objective Response Rate (ORR) (Cohorts 1, 2, and 3)

  Up to approximately 12 months (end of treatment)

• Rate of Progression of Disease within 24 Months (POD24) (Cohorts 1, 2, and 3)

  24 months

• Progression-Free Survival (PFS)

  Up to approximately 5 years

• Overall Survival (OS)

  Up to approximately 5 years

• Change From Baseline in EORTC QLQ-C30 Score

  Baseline up to approximately 5 years

Study Arms (3)

Cohort 1: Previously Untreated High-Risk FL

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Zeprumetostat

Cohort 2: Previously Untreated Low-Tumor-Burden FL

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Zeprumetostat

Cohort 3: Relapsed or Refractory FL

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Zeprumetostat

Interventions

Mosunetuzumab DRUG

Mosunetuzumab is administered via intravenous (IV) infusion. It is given with step-up dosing in Cycle 1: 1 mg on Day 1, 2 mg on Day 8, and 30 mg on Day 15. From Cycle 2 onwards, 30 mg is given on Day 1. Each treatment cycle is 28 days. Treatment continues for up to 8 to 12 cycles depending on the efficacy evaluation.

Cohort 1: Previously Untreated High-Risk FL; Cohort 2: Previously Untreated Low-Tumor-Burden FL; Cohort 3: Relapsed or Refractory FL

Zeprumetostat DRUG

Zeprumetostat is administered orally at a dose of 350 mg twice daily (BID). The treatment starts on Day 1 of Cycle 1 and continues for up to 8 or 12 cycles (each cycle is 28 days), until disease progression or unacceptable toxicity

Also known as: SHR2554

Cohort 1: Previously Untreated High-Risk FL; Cohort 2: Previously Untreated Low-Tumor-Burden FL; Cohort 3: Relapsed or Refractory FL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Shuhua Yi, Dr

CONTACT

+86-022-23909106; yishuhua@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 29, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)