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).
Signed written informed consent.
Age ≥18 years.
Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
Inability to comply with study hospitalization and restrictions.
Active infections (including tuberculosis) or immunocompromised status.
Prior history of severe hypersensitivity to similar agents.
CNS involvement of lymphoma.
Single group
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
best of complete response rate (CR)
To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
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.
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.
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.
OS
Overall Survival is defined as the time from initiation of study treatment to death from any cause.
Identification of candidate biomarkers associated with treatment response based on RNA-seq and/or whole exome sequencing (WES) data
Tumor and/or blood samples will be collected at baseline and during treatment. RNA sequencing (RNA-seq) and/or whole exome sequencing (WES) will be performed to identify gene expression signatures, somatic mutations, or pathway alterations that correlate with clinical response (e.g., CR/PR vs. SD/PD) to the combination therapy of Mosunetuzumab and Tislelizumab.
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