Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
详细描述
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD22 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up 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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria to participate in this study:
- •14-75 years old, no gender limit;
- •According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL);
- •ECOG behavior status score is 0-2 points;
- •Expected survival time ≥ 3 months;
- •No contraindications to peripheral apheresis;
- •Flow cytometry confirms that the original cells express CD22;
- •Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
- •No serious heart, lung, liver or kidney disease;
- •Ability to understand and willing to sign the informed consent form for this trial.
排除标准
- •Patients with any of the following cannot be included in this study:
- •The original cells expressing CD19 and CD22 are negative;
- •There is active infection;
- •Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
- •People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
- •HIV/AIDS patients;
- •Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
- •Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
- •Known or suspected drug abuse or alcohol dependence;
- •People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
- •Those who have participated in other clinical trials within 30 days;
- •Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
- •The investigator judged that it is not suitable to participate in this trial.
结局指标
主要结局
Complete remission rate
时间窗: From date of initial treatment to the end of follow up, up to 2 years
1. No blasts in peripheral blood, no extramedullary leukemia; 2. Three-line bone marrow hematopoietic recovery, primitive cells \<5%; 3. Peripheral blood absolute neutrophil count\>1.0×10\^9/L; 4. Peripheral blood platelet count\>100×10\^9/L; 5. No recurrence within 4 weeks
次要结局
- Overall survival rate(From admission to the end of follow up, up to 2 years.)
研究者
YuLi
Professor
Shenzhen University General Hospital