NCT04746131暂停1 期
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Diagnosed with B-NHL
- •Relapsed after or be refractory to at least 2 line of standard therapy
排除标准
- •Active central nervous system (CNS) metastases
- •Positive Direct Antiglobulin Test (DAT)
- •Active autoimmune disorder
- •Skin disorders that do not requires hormone replacement therapy
研究组 & 干预措施
IMM0306
Experimental
IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks.
干预措施: IMM0306 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
时间窗: End of Study (52 Weeks)
DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.
次要结局
未报告次要终点
研究者
研究点 (1)
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