Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events that related to treatment
研究概览
简要总结
This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
详细描述
There are limited options for treatment of relapse/refractory CD19+ B Cell Leukemia and Lymphoma. CD19 is expressed on most CD19+ B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
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
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
- •Failed to standard chemotherapy regimens;
- •Relapse after complete remission, high-risk and / or refractory patients ;
- •Relapse after hematopoietic stem cell transplantation;
- •For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
- •Evidence for cell membrane CD19 expression;
- •All genders, ages: 3 to 75 years；
- •The expect time of survive is above 12 weeks;
- •No serious mental disorders ;
- •Left ventricular ejection fraction ≥50%
- •Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- •Sufficient renal function defined by creatinine clearance≤2 x ULN;
- •Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- •With single or venous blood collection standards, and no other cell collection contraindications;
- •Ability and willingness to adhere to the study visit schedule and all protocol requirements.
排除标准
- •Have received CAR-T therapy or other genetically modified cell therapy before screening；
- •Participated in other clinical research within 1 month before screening；
- •Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
- •Live attenuated vaccine within 4 weeks before screening;
- •Convulsion or stoke within past 6 months;
- •Previous history of other malignancy;
- •Presence of uncontrolled active infection;
- •Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
- •Pregnant or breasting-feeding women;
- •Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
结局指标
主要结局
Adverse events that related to treatment
时间窗: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The response rate of CD19 CAR-T treatment in patients with relapse/refractory CD19+ B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy
时间窗: 6 months
The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
次要结局
- Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma(2 years)
- Quantity of CD19 CAR copies in bone marrow and peripheral blood(2 years)
- Levels of Cytokines in Serum(3 months)
- Overall survival(OS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma(2 years)
- Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma(2 years)
- Rate of CD19 CAR-T cells in bone marrow and peripheral blood(2 years)
- Cellular kinetics of CD19 positive cells in bone marrow(1 years)