NCT01161511已完成1 期
A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- To determine the dose limiting toxicities
研究概览
简要总结
This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.
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 CLL/SLL
- •at least 18 years of age
- •able to receive outpatient treatment and follow-up at the treating institution
- •completed all CLL therapies > 4 weeks prior to first study dose
排除标准
- •previously treated with an anti-CD19 antibody therapy
- •undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease
- •active Richter's syndrome
- •designated Class III or IV by the New York Heart Association (NYHA) criteria
- •history of myocardial infarction or stroke within the last 6 months
- •active viral, bacterial, or systemic fungal infection requiring treatment
- •HIV or Hepatitis C positive
- •Hepatitis B infection
结局指标
主要结局
To determine the dose limiting toxicities
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (6)
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