Phase 1/2a, Single Dose Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 16
- 主要终点
- Participants That Experienced Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK), activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia (AML).
详细描述
This 2-part first in human (FIH) study is comprised of two open-label arms. It is a multi-center, Phase 1/2a study evaluating the safety and activity of NTLA-5001 in subjects with persistent or recurrent Acute Myeloid Leukemia after first-line or later therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
Participants That Experienced Dose-limiting Toxicities (DLTs)
时间窗: Primary DLT assessment from NTLA-5001 infusion up to 28 days post-infusion
DLTs were defined as events with onset within 28 days of infusion. AEs were collected from time of informed consent through the Week 112 visit. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0. Severity of AEs was assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 toxicity grading criteria. The measure reported below for the primary outcome consists of DLT data only. Adverse events are reported in the Adverse Event section of this presentation.
次要结局
- Frequency of NTLA-5001 T-cell Receptor (TCR) Transgene Copy Number in the Peripheral Blood(From NTLA-5001 infusion up to 4 weeks post-infusion)
- Tumor Response in Participants With AML(From NTLA-5001 infusion up to 4 weeks post-infusion)
- Response Duration in Participants With AML(From NTLA-5001 infusion up to 4 weeks post-infusion)
- Persistence of NTLA-5001 T Cell Receptor (TCR) Transgene Copy in Peripheral Blood(From NTLA-5001 infusion up to 4 weeks post-infusion)
- Disease Progression in Participants With AML(From NTLA-5001 infusion up to 4 weeks post-infusion)