Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
研究概览
简要总结
This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- 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
- 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- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
- •Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- •Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.
排除标准
- •GVHD Grades II-IV for patients who had previously been transplanted;
- •Any cell therapy in the previous 30 days;
- •Patient with concomitant life-threatening infectious disease;
- •Lansky/Karnofsky score <60;
- •Patients with hepatic or renal disease as specific above;
- •Pregnant or breast-feeding females;
- •Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
结局指标
主要结局
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
时间窗: Baseline and day 28
At baseline and at Day 28 after infusion: lymphoblasts \< 5% at morphological evaluation of bone marrow aspirate
To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12
时间窗: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts \< 5% at morphological evaluation of bone marrow aspirate
次要结局
未报告次要终点