CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Completeremission
研究概览
简要总结
Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
- •Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
- •With an estimated survival of higher than 3 months (according to investigator's judgement);
- •Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine < 1.6 mg/dL, aspartate aminotransferase/aspartateaminotransferase < 3 x upper limit of normal, bilirubin <2.0 mg/dL;
- •Karnofsky performance status ≥ 60 or ECOG ≤ 2.
排除标准
- •Intolerant to immunosuppressive chemotherapies;
- •With active infection or other uncontrolled complications;
- •With history of seizure;
- •Active hepatitis B or hepatitis C infection and HIV infection;
- •Pregnant or lactating women, or patients refusing to take effective contraception measures;
- •Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).
研究组 & 干预措施
CAR T-cell therapy
Patients enrolled will receive infusion of CD19-targeting CART-cells
干预措施: CAR T-cell therapy (Biological)
结局指标
主要结局
Completeremission
时间窗: 1 month post infusion
defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery
Minimal residual disease response
时间窗: 1 month post infusion
defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection
Leukemia-free survival
时间窗: 3 year post infusion
calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up
次要结局
- Overall survival(3 year post infusion)
- Cumulative incidence of relapse(3 year post infusion)