Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
Trial Parameters
Brief Summary
This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.
Eligibility Criteria
Inclusion Criteria: * Participants must meet all of the following inclusion criteria in order to be included in this study; * Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited; * Special criteria for different indications: * Subjects with relapsed/refractory moderate to severe SLE must meet the following criteria: * According to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE; * Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and/or positive for anti dsDNA antibody, and/or positive for anti Sm antibody during screening; * The definition of moderate to severe activity is: SLEDAI-2000 score ≥ 8 during screening; If there is a low complement and/or anti dsDNA antibody score, the clinical symptom score for SLEDAI-2000 (excluding low complement and/or anti dsDNA antibodies) must be ≥ 6 points; * At least 6 months of stable standard treatment have been us