CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Trial Parameters
Brief Summary
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Eligibility Criteria
Inclusion Criteria: * 1\. Age ≥18 years old; * 2\. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard. * 3\. SLEDAI-2K ≥8 during screening * 4\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type); * 5\. Expected survival \>12 weeks; * 6\. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known); * 7\. Volunteer to participate in this experiment and sign the informed consent. Exclusion Criteria: * 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cere