NCT01957579已完成1 期
A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
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
- 20 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese men or women at least 20 years of age
- •Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
- •Karnofsky Performance Status ≥70;
- •Life expectancy of ≥12 weeks
排除标准
- •Any available standard line of therapy known to be life-prolonging or life-saving
- •Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- •Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
研究组 & 干预措施
MEDI-551
Experimental
干预措施: MEDI-551 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From baseline to 30 days after the last dose of study drug
次要结局
- MEDI-551 Trough Concentration Levels at Day 28(Day 28)
- MEDI-551 Trough Concentration Levels at Day 140(Day 140)
- Number of Participants With Tumour Response in FL Patients(From the baseline to 30 days after the last dose of study drug)
- MEDI-551 Trough Concentration Levels at Day 56(Day 56)
- MEDI-551 Trough Concentration Levels at Day 168(Day 168)
- Number of Participants With Tumour Response in DLBCL Patients(From the baseline to 30 days after the last dose of study drug)
- MEDI-551 Trough Concentration Levels at Day 112(Day 112)
- Anti-MEDI-551 Antibodies(From baseline to 30 days after the last dose of study drug)
- MEDI-551 Trough Concentration Levels at Day84(Day 84)
- Number of Participants With Dose Limiting Toxicities(From baseline to 28 days after the first dose of study drug)
- Maximum Tolerated Dose(From baseline to 28 days after the first dose of study drug)
- MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)(Day 0 (pre-dose))
- MEDI-551 Trough Concentration Levels at Day 7(Day 7)
- Number of Participants With Tumour Response in CLL Patients(From the baseline to 30 days after the last dose of study drug)
- Number of Participants With Tumour Response in MM Patients(From the baseline to30 days after the last dose of study drug)
研究者
研究点 (1)
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