A Phase 2 interventional study of Mosunetuzumab and Zeprumetostat in Follicular Lymphoma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
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.
This is a prospective, open-label, multicenter, multi-cohort phase 2 study evaluating Mosunetuzumab combined with Zeprumetostat (SHR2554) in follicular lymphoma (FL). The study is conducted in two stages:
Stage 1: Safety Run-in Phase Initially, 6 participants in Cohort 1 will be enrolled to evaluate dose-limiting toxicities (DLTs) during Cycle 1 (28 days). If the safety is acceptable, the study will proceed to Stage 2.
Stage 2: Expansion Phase
Enrollment will expand to three independent cohorts:
Cohort 1: Previously untreated high-risk FL (FLIPI 3-5). Cohort 2: Previously untreated low-tumor-burden FL. Cohort 3: Relapsed or refractory FL.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's planned enrollment of 80 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort 1- Previously Untreated High-Risk FL：
Cohort 2- Previously Untreated Low-Tumor-Burden FL：
Cohort 3-Relapsed or Refractory FL：
Exclusion Criteria:
Drug: Mosunetuzumab · Drug: Zeprumetostat
Drug: Mosunetuzumab · Drug: Zeprumetostat
Drug: Mosunetuzumab · Drug: Zeprumetostat
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.
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
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
Time frame: 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.
Time frame: Up to 3 years
Objective Response Rate (ORR) (Cohorts 1, 2, and 3)
Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) during the treatment period, assessed according to the Lugano 2014 classification
Time frame: Up to approximately 12 months (end of treatment)
Rate of Progression of Disease within 24 Months (POD24) (Cohorts 1, 2, and 3)
Percentage of participants experiencing disease progression within 24 months from the initiation of treatment
Time frame: 24 months
Progression-Free Survival (PFS)
The time from the start of treatment to disease progression or death from any cause.
Time frame: Up to approximately 5 years
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Time frame: Up to approximately 5 years
Change From Baseline in EORTC QLQ-C30 Score
Evaluated using the EORTC QLQ-C30 questionnaires to assess health-related quality of life and disease-specific symptoms. Scores are transformed to a 0 to 100 scale. For global health status/quality of life and functional scales, higher scores indicate better functioning or quality of life. For symptom scales/items, higher scores indicate greater symptom burden or worse symptoms.
Time frame: Baseline up to approximately 5 years
Change From Baseline in FACT-Lym LYMS Score
The Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LYMS) score ranges from 0 to 60, with higher scores indicating better lymphoma-specific quality of life and fewer lymphoma-related symptoms. Evaluated using the FACT-Lym LYMS questionnaires to assess health-related quality of life and disease-specific symptoms.
Time frame: Baseline up to approximately 5 years
Incidence and Severity of Adverse Events (AEs)
Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0.
Time frame: Up to approximately 5 years
Plan to share: No
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Institute of Hematology & Blood Diseases Hospital, China