CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus

Inclusion Criteria

• •1\. Able to sign Informed Consent Form (ICF) ;
• •2\. Males or females 18-70（include 18 and 70） years of age;
• •3\. Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) 1997 or European League against Rheumatism(EULAR)/ the American College of Rheumatology (ACR) 2019 criteria .Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) 1997 or European League against Rheumatism(EULAR)/ the American College of Rheumatology (ACR) 2019 criteria .
• •Group1:Have active, biopsy-proven proliferative lupus nephritis Class III or IV, or Class V using the 2003 ISN/RPS criteria. The biopsy must be performed in the 6 months prior to the screening visit or during the screening period. Have documentation of active renal disease defined as:24h Proteinuria\> 1.5 grams/day.
• •Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MMF, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.
• •Group 2: Refractory thrombocytopenia: No response to treatment with at least 1 course of MP shock (1g for 3 days) or high dose of glucocorticoids (1mg/kgd equivalent dose of glucocorticoids) combined with 1 or more immunosuppressants. Before enrollment, at least 2 consecutive blood routine tests were performed to check platelets below 50×10\^9/L and above 30×10\^9/L. Other non-SLE causes of thrombocytopenia, such as infection, bone marrow suppression, and hypersplenism, were excluded.
• •4\. Not pregnant or nursing.
• •5\. Adequate organ functions indicated as: ALT and AST \< 3 times of the ULN； Total bilirubin \< 2mg/dL with the exception of patients with Gibert-Meulengracht syndrome, who may be included if their total bilirubin is \< 3 x ULN and direct bilirubin \< 1.5mg/dL ULN； An estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2 at the screening visit Serum creatinine ≤1.5mg/dl(133umol/l); Must have a minimum level of pulmonary reserve, non-oxygenated blood oxygen saturation \>95%;
• •6\. Lymphocyte count \> 0.4×10\^9/L；
• •7\. Use a small dose of glucocorticoid (dose equivalent to ≤10mg/d prednisone) for not less than 1 month (except glucocorticoid intolerance).