Autoimmune Diseases
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
Detailed description
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors. CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.
Interventions
DRUGCAR-T
CAR-T cells
Sponsors
Beijing Boren 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
1. Male or female, between 18 and 56 years old; 2. Diagnosed with Autoimmune Diseases； 3. Good organ functions; 4. Voluntary participates this trial and can comprehend and sign ICF.
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 ContactYajing Zhang, MD/PhD
Outcome results
None listed