Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
Trial Parameters
Brief 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.
Eligibility Criteria
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 to maintain low disease activity or a SLEDAI 2K score (see attachment 3) of 8 or higher. 2. Recurrence of disease activity after failure of conventional therapy or after remission. Definition of conve