Autoimmune Diseases
Conditions
Keywords
autoimmune diseases
Brief summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.
Detailed description
This is a single center, one-arm, open label study aiming to evaluate the safety and efficacy of CAR-T cells therapy in subjects with autoimmune diseases.
Interventions
DRUGCAR-T cell
CAR-T cell
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female, between 18 and 65 years old; 2. Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia, Pemphigus； 3. Good organ functions; 4. Subjects must understand and personally, voluntarily sign and date an informed consent. Key
Exclusion criteria
1. Had or has active malignancy; 2. Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products; 3. Combined with other autoimmune disease that needs systemic treatment or therapy; 4. Pregnant or lactating women; 5. Has other factors that deemed not suitable by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity | 0~28 day after treatment |
| Frequency of adverse events, serious adverse events | within 24 months after treatment |
Countries
China
Contacts
Primary ContactFei Sun
Outcome results
None listed