NCT04106076撤回1 期
Phase I, Open Label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of Multiple Infusions of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor) in Patients With Adverse Genetic Risk Acute Myeloid Leukaemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of AE/SAE/DLT [Safety and Tolerability]
研究概览
简要总结
This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017)
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •No prior gene or experimental cellular therapy
- •No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy
排除标准
- 未提供
结局指标
主要结局
Incidence of AE/SAE/DLT [Safety and Tolerability]
时间窗: 24 months
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study
次要结局
未报告次要终点
研究者
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