NCT00105313终止1 期
A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 22
- 主要终点
- To determine the maximum tolerated dose (MTD) or the optimal biological dose
研究概览
简要总结
For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.
For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To determine the maximum tolerated dose (MTD) or the optimal biological dose
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
CD-2 positive lymphoproliferative disorders.
次要结局
未报告次要终点
研究者
研究点 (22)
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