Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.
| Condition(s) | Autoimmune Diseases |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases. |
| Who can participate | Inclusion Criteria: 1\. Systemic lupus erythematosus (SLE) 1.1. Refractory systemic lupus erythematosus (SLE) and / or refractory lupus nephritis (LN) 1. Male or female patients, aged 3-65 years (including 3 and 65 years); 2. Systemic lupus erythematosus that meets the 2019 American Society of Rheumatology (ACR) / European Association of Rheumatology Consortium (EULAR) classification criteria (see Annex 2); 3. Nuclear antibody (ANA) test is clearly positive, namely ANA titer 1:80 (based on the equivalent results of Hep-2 immunofluorescence or enzyme immunoassay) and / or the test at the screening visit (based on ELISA test, 30 IU / mL). 4. Refractory systemic lupus erythematosus (SLE) and / or refractory lupus nephritis (LN): <!-- --> 1. Patients take at least 7.5 mg of prednisolone daily |
| Ages | 3 Years to 65 Years |
| Sex | All |
| Lead sponsor | Beijing GoBroad Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-11-23 |
| NCT ID | NCT06688799 |
| Official listing | https://clinicaltrials.gov/study/NCT06688799 |