Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases
Trial Parameters
Brief Summary
This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
Eligibility Criteria
Inclusion Criteria: 1. Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed. 2. Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria : 1. Systemic lupus erythematosus (SLE); 2. Rheumatoid arthritis (RA); 3. Systemic scleroderma (SSc) ; 4. Sjogren's Syndrome (SS); 5. Polymyositis/dermatomyositis (PM/DM); 6. Mixed connective tissue disease (MCTD). 3. Researchers determine that the disease is in an active stage; 4. At least one autoantibody is positive in the serum or plasma during the screening period; 5. Insufficient response, intolerance or recurrence to at least one standard treatment; 6. The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures througho