CD19-BAFF Targeted CAR T-cells: Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
Study summary
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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:
1. Lymphocyte count\>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;
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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) — Up to 28 years after Treatment Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after Treatment Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of medical college of zhejiang university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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