NCT00108108终止1 期
An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- to determine the maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
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
- •Clinical diagnosis of CLL requiring treatment
- •Refractory or relapsed disease
- •Prior treatment with fludarabine
- •Male or Female
- •>18 years of age
排除标准
- •Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
- •Clinically significant cardiac dysfunction or other significant organ dysfunction
- •Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
研究组 & 干预措施
HCD122
Experimental
干预措施: HCD122 (Drug)
结局指标
主要结局
to determine the maximum tolerated dose (MTD)
时间窗: between study Day 1 and study Day 50
次要结局
- To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients(between study Day 1 and study termination)
- To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients(between study Day 1 and study termination)
- To assess preliminary anti-tumor activity of HCD122 in dose escalation patients(between study Day 1 and study termination)
- to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients(between study Day 1 and study termination)
研究者
研究点 (5)
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