NCT00730652撤回1 期
A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Bristol-Myers Squibb0 个研究点目标入组 34 人开始时间: 2009年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 34
- 主要终点
- Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
研究概览
简要总结
To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.
详细描述
Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.
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
- •Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
- •Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
- •For MCL, must have measurable disease
- •At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
- •At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
- •ECOG Performance Status 0 to 2;
- •No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;
排除标准
- •History of severe hypersensitivity reactions to other monoclonal antibodies;
- •Use of other investigational drugs within 30 days before study drug administration
- •Prior treatment with any other anti-CD70 antibody;
- •Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
- •Evidence of bleeding diathesis or coagulopathy;
- •Active autoimmune disease requiring immunosuppressive therapy;
- •Known current drug or alcohol abuse;
- •Underlying medical conditions that will make the administration of MDX-1411 hazardous
研究组 & 干预措施
MDX1411
Experimental
An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.
干预措施: MDX-1411 (Biological)
结局指标
主要结局
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
时间窗: Day 1-40
次要结局
未报告次要终点
研究者
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