NCT05446688尚未招募2 期
A Phase 2, Multicenter, Non-Randomized, Open-Label, Single-Arm Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Relapsed or Refractory Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.
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
- •Voluntarily participate in the study and sign the informed consent.
- •Age≥18 years.
- •Subjects with relapsed or refractory lymphoma.
- •Subjects with at least one measurable tumor lesion.
- •Life expectancy≥3 months.
- •Adequate organ functions.
排除标准
- •Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks.
- •Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months.
- •Subjects with primary or secondary CNS lymphoma.
- •History of another malignancy within 3 years before the first dose of investigational drug.
- •History of active autoimmune diseases.
- •Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug.
- •Subjects who experienced grade 3 or above immune-related adverse events (irAE) .
- •Documented history of uncontrolled systemic diseases.
- •Subjects who were allergic to any composition of investigational drug.
- •Major surgery within 28 days prior to first dose of investigational drug.
- •Subjects with active infection.
- •Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
- •Subjects with poor treatment compliance.
- •Use of any investigational drug or device within 28 days prior to the first dose of investigational drug.
- •Live vaccine was administered within 28 days prior to first dose of investigational drug.
- •Pregnant or lactating women.
研究组 & 干预措施
6MW3211
Experimental
6MW3211 injection, 45mg/kg, Q2W
干预措施: 6MW3211 (Drug)
结局指标
主要结局
Objective response rate
时间窗: 1 Year
Defined as the percentage of subjects who experience a best response of either CR or PR
次要结局
- Complete response rate(1 Year)
- Duration of response(1 Year)
- Time to response(1 Year)
- Progression free survival(1 Year)
- Incidence of adverse events(Up to 28 days post last dose)
- PK Parameter(1 Year)
- Overall survival(1 Year)
研究者
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