Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

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 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 a history of present illness of vital organs such as the heart, liver,kidney 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.
• •Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.