A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- best of complete response rate (CR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •ECOG performance status 0-
- •Expected survival ≥12 weeks.
- •Measurable disease (longest diameter >1.5 cm).
- •Adequate organ function:
- •Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.
- •Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.
- •Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
- •Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.
排除标准
- •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.
- •Pregnant or breastfeeding women.
- •Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
- •Receipt of live attenuated vaccines within 4 weeks before enrollment.
- •Use of systemic immunosuppressants within 2 weeks prior to first dose.
- •History of drug or alcohol abuse in the past 12 months.
- •Any condition deemed inappropriate for study participation by the investigator.
研究组 & 干预措施
combination therapy of Mosunetuzumab and Tislelizumab
干预措施: Mosunetuzumab (Drug)
combination therapy of Mosunetuzumab and Tislelizumab
干预措施: Tislelizumab (Drug)
结局指标
主要结局
best of complete response rate (CR)
时间窗: up to the end of 8/17 cycles of treatment(each cycle 21 days)
To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
次要结局
- Overall Response Rate (ORR)(up to the end of 8/17 cycles of treatment(each cycle 21 days))
- Duration of Response (DoR)(up to 2 years)
- Progression-free survival (PFS)(Assessed every 3 months during follow-up, up to 2 years)
- OS(Assessed every 3 months during follow-up, up to 2 years)
研究者
Huilai Zhang
Director of lymphoma department
Tianjin Medical University Cancer Institute and Hospital