Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus

Inclusion Criteria: 18-70 years old; Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria; SELENA-SLEDAI≥8; Patients with CD19+ B-cell; Active organ involvement; Hemoglobin≥85 g/L; WBC≥2.5×10^9/L NEUT≥1×10^9/L; PLT≥50×10^9/L; AST/ALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL/min; blood bilirubin ≤2.0 mg/dl; echocardiography indicates that the ejection fraction is ≥50%; Adequate venous access for apheresis, and no other contraindications for leukapheresis; Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline. Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion. Agree to attend follow-up visits as required; Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative; Exclusion Criteria: Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks prior to leukapheresis, or subjects who need prohibited drugs to treat active nephritis or subjects who need hemodialysis; CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts; Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system; Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers; Received immunosuppressive therapy within 1 week prior to leukapheresis; Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus; Patients with syphilis infection; The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening; Received live vaccine treatment within 4 weeks prior to screening; Severe allergies or hypersensitivity; Contraindication to cyclophosphamide in combination with fludarabine; Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion; cannula or drainage tubes other than central venous catheters; Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment; Subjects with prior CD19 or BCMA-targeted therapy Participated in any clinical study within 3 months prior to enrollment Any situations that the investigator believes the patients are not suitable for the study.