NCT05805943招募中1 期
Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
- •At least one measurable or assessable tumor lesion.
- •Adequate organ and hematologic function.
- •Eastern Co-operative Oncology Group (ECOG) score 0 to
- •All adverse events from prior treatment must be CTCAE v5.0 grade <= 1
排除标准
- •Active central nervous system (CNS) lymphoma.
- •Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day).
- •History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3).
- •Have evidence of severe uncontrollable active infection.
- •Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
研究组 & 干预措施
IMM0306 Monotherapy
Experimental
Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level.
Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.
干预措施: IMM0306 (Drug)
结局指标
主要结局
Complete response rate
时间窗: up to 52 weeks
Dose-limiting toxicity
时间窗: Evaluated for DLTs during the first 28-day cycle
次要结局
未报告次要终点
研究者
研究点 (1)
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