A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07031700
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Relapsed/Refractory Follicular Lymphoma

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    * Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg * Cycles 2-8: 30 mg every 3 weeks * Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.
  • Tislelizumab — DRUG
    \- Cycles 2-8: 200 mg IV every 3 weeks

Study Details

This is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination therapy of Mosunetuzumab and Tislelizumab

Primary Outcome Measure

best of complete response rate (CR) [ Time Frame: up to the end of 8/17 cycles of treatment(each cycle 21 days) ]

Central Contacts

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