NCT02808442已完成1 期
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 11
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.
- •Estimated life expectancy ≥ 12 weeks
- •Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50
排除标准
- •Burkitt leukemia
- •CD19-negative B-cell leukemia
- •Active Central Nervous System (CNS) leukemia
- •Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion
- •Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped
- •History of CRS grade 4 related to previous CAR T cell therapy
- •Contraindication to Alemtuzumab administration
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: From inclusion to Month 12
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Molecular Remission Rate(At Day 28 after the first UCART19 infusion)
研究者
研究点 (11)
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