A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
详细描述
In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.
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
- •Age ≥18 years old;
- •A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
- •SLEDAI-2K ≥8 during screening
- •failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
- •Expected survival >12 weeks;
- •Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);
- •Volunteer to participate in this experiment and sign the informed consent.
排除标准
- •History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Active infected persons who are not cured:
- •Active hepatitis B or C virus infection;
- •Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
- •Have used any gene therapy products before;
- •Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals;
- •ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;
- •Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
- •HIV-infected people;
- •Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
研究组 & 干预措施
Lupus Nephritis
Administration of CD19/BCMA Lupus Nephritis Targeted CAR T-cells
干预措施: CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection (Biological)
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
- Urinary protein index(Up to 24 hours after Treatment)
研究者
He Huang
Clinical Professor
Zhejiang University