Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 19
- 主要终点
- Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B-ALL blast cells expressing CD22
- •Diagnosed with R/R B-ALL
- •Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen
排除标准
- •Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment
研究组 & 干预措施
Dose Escalation
Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D)
Dose Expansion: UCART22 administered at the RP2D
干预措施: UCART22 (Biological)
Dose Escalation
Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D)
Dose Expansion: UCART22 administered at the RP2D
干预措施: CLLS52 (Biological)
结局指标
主要结局
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
时间窗: Up to D28 post initial UCART22 infusion
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 in relation to UCART22 and/or lymphodepletion
次要结局
- Duration of Response(From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24)
- Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)(At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24)
- Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion(Lymphodepletion to Day 56)
- Progression Free Survival(From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24)
- Overall Survival(From the first day of study treatment to the date of death from any cause, assessed up to Month 24)