A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Adverse Events That Are Related to Treatment
研究概览
简要总结
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.
详细描述
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- •Measurable disease and adequate organ function as specified in the protocol
排除标准
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
- •Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day
- •Prior autologous stem cell transplant within 3 months
- •Active Hepatitis B or Hepatitis C
研究组 & 干预措施
Cohort A
Cosibelimab (TG-1501) single-agent
干预措施: Cosibelimab (Drug)
Cohort B
Cosibelimab + Ublituximab + Bendamustine combination
干预措施: Cosibelimab + Ublituximab + Bendamustine combination (Drug)
Cohort C
Cosibelimab + Ublituximab + Bendamustine combination
干预措施: Cosibelimab + Ublituximab + Bendamustine combination (Drug)
结局指标
主要结局
Adverse Events That Are Related to Treatment
时间窗: 6 months of therapy
Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
次要结局
- Overall Response Rate(Up to 12 months)