Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research

Inclusion Criteria: * All subjects or guardians must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process; * Be over 18 years of age, male or female; * A diagnosis of SLE according to the 2012 systemic lupus international collaborating clinics(SLICC); * The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening: 1. Conventional regimens for SLE are corticosteroids and one or more immunomodulatory drugs over 6 months; 2. Oral corticosteroids must meet the following requirements: * Prednisone (or equivalent) ≥7.5 mg/ day, and ≤60 mg/ day; * There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants; * At least 8 weeks of treatment prior to screening, and the dose must be kept stable for \> 2 weeks. * SLEDAI-2000 score ≥8 during the screening period. Score ≥6 for SLEDAI-2000 clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present; * Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo; * CD19 expression was positive by or flow cytometry ; * Organ function: 1. Complete blood count (CBC) test \[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\] * Lymphocyte count ≥ 0.5×10\^9/L; * Platelet count ≥ 25×10\^9/L; * Hemoglobin ≥ 70.0 g/L 2. Blood Biochemistry: * Serum creatinine (Scr) ≤ 1.5 x ULN, or * endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula); * alanine aminotransferase (ALT) ≤ 2.5 x ULN; * aspartate aminotransferase (AST) ≤ 2.5 ×ULN; * Total bilirubin (TBIL) ≤ 2 ×ULN; Subjects with total bilirubin \< 3 × ULN and direct bilirubin \< 1.5× ULN with Gilbert-.Meulengracht syndrome could be included; * Serum lipase and amylase ≤ 1.5×ULN; * Alkaline phosphatase (ALP) ≤ 2.5 ×ULN. 3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) \> 91% in indoor air environment.. * Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%. Exclusion Criteria: * Prior to screening, other lupus crises, such as active central nervous system lupus, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis. * Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. * History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation. * IgA deficiency was present during screening (serum IgA level \< 10 mg/dL). * Other conditions that the investigator considered should not be enrolled in this clinical study.