NCT03389035已完成1 期
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
Fondazione Matilde Tettamanti Menotti De Marchi Onlus4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年12月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Dose Limiting Toxicities (DLT):
研究概览
简要总结
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (1-17) and adults (18-75 years old);
- •Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
- •Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- •Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
- •No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- •No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
排除标准
- •Patients with GVHD Grades II-IV;
- •Any cell therapy in the last 30 days;
结局指标
主要结局
Dose Limiting Toxicities (DLT):
时间窗: 1 month
rate and severity of the cytokine release syndrome (CRS)
次要结局
未报告次要终点
研究者
研究点 (4)
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