Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus

Inclusion Criteria:

1. Age:≥5 years old;

2. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；Stillin moderate to severe disease activity despite ≥3M of high doseglucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ),hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF,azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide,telitacicept, Beliumab, and rituximab); or Intolerant to standard treatments;

3. SLEDAI 2K score≥8 points;

4. The functions of important organs are basically normal: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obviousabnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2； Liverfunction: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No seriouslung lesions, SpO2≥92%;

5. Met the standards of leukapheresis or intravenous blood collection, Nocontraindication for cell collection;

6. Negative pregnancy test for female Subjects of childbearing age, agree to takeeffective contraceptive measures the first year after CAR-T infusion;

7. Participants or their guardians agrees to participate in the clinical trial and signthe informed consent form which indicating that he/she understands the purpose andprocedure of the clinical trial and is willing to participate in the study.

Exclusion Criteria:

1. Received CAR T cell therapy previously;

2. Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60days);

3. Severe acute nephritis: Patients who have accepted or was undergoing renalreplacement therapy within 3 months prior to transfusion; Or in the investgator'sopinion, patients who is likely to have significant kidney disease within 3 moths ofthe study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day orequivalent amount of other steriod), cyclophosphamide, or MMF treatment;

4. Have a history of congenital heart disease or acute myocardial infarction within 6months prior to screening; Or severe arrhythmias (including multisource frequentsupraventricular tachycardia, ventricular tachycardia, etc.); Or combined withmoderate to massive pericardial effusion, serious myocarditis, etc; Or patients withunstable vital signs who need hypertensive drugs；

5. Suffer from other diseases that require long-term use of glucocorticoid or high-doseof immunosuppressive agents;

6. Uncontrollable infection, or active infection that requires systemic treatmentwithin 1 week prior to screening；

7. History of organ transplantation or hematopoietic stem cell transplantation, or ≥Grade 2 GVHD within 2 weeks prior to screening；

8. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positiveand peripheral blood hepatitis B virus (HBV) DNA titer greater than the normalreference value range; Or hepatitis C virus (HCV) antibody positive and peripheralblood hepatitis C virus (HCV) RNA titer greater than the normal reference valuerange; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilistest positive; Or cytomegalovirus (CMV) DNA test positive;

9. Received live vaccine within 4 weeks before screening;

10. Tested positive in Blood pregnancy test；

11. Previous or concurrent malignancy；

12. Patients who participated in other clinical study within 3 months prior toenrollment;

13. Any other conditions that the investigators deem it unsuitable for the study.