A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
详细描述
In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Gender unlimited，18< Age;
- •2. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma
- •3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
- •CR not achieved after standardized chemotherapy;
- •CR achieved following the first induction, but CR duration is less than 12 months;
- •Ineffectively after first or multiple remedial treatments;
- •2 or more relapses;
- •4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
- •5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
- •6. Relapsed or refractory B-NHL (meeting one of the following conditions):
- •No response or relapse after second-line or above chemotherapy regimens;
- •Primary drug resistance;
- •Relapse after auto-HSCT;
- •7. At least one assessable tumor lesion per Lugano 2014 criteria;
- •8. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- •9. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •10. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- •11. Estimated survival time ≥ 3 months;
- •12. ECOG performance status 0 to 2;
- •13. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- •2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •3. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion
- •4. Patients with HIV infection;
- •5. Active infection of hepatitis B virus or hepatitis C virus;
- •6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •7. Other uncontrolled diseases that were not suitable for this trial;
- •8. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
- •9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 28 years after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Duration of remission ,DOR(Up to 1 years after CAR-T infusion)
- Overall response rate ,ORR(Up to 12 weeks after CAR-T infusion)
- Overall survival, OS(Up to 1 years after CAR-T infusion)
- Event-free survival, EFS(Up to 1 years after CAR-T infusion)
研究者
He Huang
Clinical Professor
Zhejiang University