autoimmune diseases
Conditions
Interventions
Sponsors
the First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosed as an autoimmune disease (including systemic lupus erythematosus, scleroderma, immune nephritis, Sjogrens syndrome), and the conventional treatment has poor efficacy and/or no effective treatment; or allogeneic hematopoietic stem cells HLA antibody positive before transplantation; 2) Expected survival> 12 weeks; 3) Women of childbearing age who had a negative urine pregnancy test before the start of the administration and agreed to take effective contraceptive measures during the trial period until the last follow-up; 4) Voluntary participation in this trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patient with a history of epilepsy or other central nervous system diseases; 2) Patient with prolonged QT period or severe heart disease; 3) Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4) Uncured patients with active infection; 5) patient with active hepatitis B or hepatitis C virus infection; 6) Combined use of systemic steroids within 4 weeks before participating in treatment (except those who are using inhaled steroids recently or currently) 7) Those who have used any gene therapy products before; 8) Those with insufficient amplification ability in response to CD3/CD28 costimulatory signals (2.5mg/dl or ALT/AST>3 times of the normal value or bilirubin >2.0 mg/dl; 10) Those who suffer from other uncontrolled diseases and the investigator considers it unsuitable to join; 11) Those who are infected with HIV; 12) The investigator believes that it may increase the risk of the subject or any situation that interferes with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limited toxicity;adverse event incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| titer of auto-antibody; | — |
Countries
China
Contacts
Public ContactHe Huang
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed