Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07555470
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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 Dates

Start date
Apr 10, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Best Complete Response (CR) Rate (Cohort 1 and Cohort 3) [ Time Frame: Up to approximately 12 months (From start of treatment until the end of up to 12 cycles of treatment) ]

Central Contacts

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