Autoimmune Diseases
Conditions
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 study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of CAR-T Cells to treating Subjects with Autoimmune Diseases.
Interventions
DRUGCAR-T cell
CAR-T cell
Sponsors
Zhejiang University
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； 3. Good organ functions; 4. Voluntary participates this trial and can comprehend and sign ICF. Key
Exclusion criteria
1. Had or has active malignancy; 2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy; 3. Combined with other autoimmune disease that needs treatment; 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 AEs, SAEs | 0 day to 24 months after treatment |
Countries
China
Contacts
Primary ContactHe Huang, MD/PhD
Outcome results
None listed