Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 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 Autoimmune Diseases.
详细描述
In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica 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 Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases 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\0.3×10e9/L;
- •2. Neutrophils ≥0.5×10e9/L;
- •3. Hemoglobin ≥60g/L;
- •4. Platelet ≥30×10e9/L
- •* 5\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- •* 6.Those who voluntarily participated in this trial and provided 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 or lactating women (the safety of this therapy for unborn children is still unknown)
- •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. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L;
- •8. Any unsuitable to participate in this trial judged by the investigator;
- •9. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
- •10. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
- •11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
- •12. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
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 Treatment)
- Multiple Myeloma (MM), Overall response rate (ORR)(Up to 2 years after Treatment)
- Progression-free survival (PFS)(Up to 2 years after Treatment)
研究者
He Huang
Clinical Professor
Zhejiang University