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).
The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
* 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.
\- Cycles 2-8: 200 mg IV every 3 weeks
best of complete response rate (CR)
To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)
Overall Response Rate (ORR)
Objective Response Rate is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment with Mosunetuzumab and Tislelizumab, as assessed according to Lugano 2014 criteria.
Time frame: up to the end of 8/17 cycles of treatment(each cycle 21 days)
Duration of Response (DoR)
Duration of Response is defined as the time from the first documentation of objective response (CR or PR) to the first documentation of disease progression or death from any cause, whichever occurs first. Response will be assessed per Lugano 2014 criteria.
Time frame: up to 2 years
Progression-free survival (PFS)
Progression-Free Survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.
Time frame: Assessed every 3 months during follow-up, up to 2 years
OS
Overall Survival is defined as the time from initiation of study treatment to death from any cause.
Time frame: Assessed every 3 months during follow-up, up to 2 years
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