Overview
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
Description
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.
Eligibility
Inclusion Criteria:
- 1. Gender unlimited，18<Age;
- 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
- 3. Estimated life expectancy of minimum of 12 weeks;
- 4. The blood routine meets the following standards:
- Lymphocyte count>0.3×10e9/L;
- Neutrophils ≥0.5×10e9/L;
- Hemoglobin ≥60g/L;
- 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;
Exclusion Criteria:
- 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.