IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)

Exclusion Criteria

• •Disease-related:
• •1. Diagnosed with drug-induced SLE.
• •2. Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis, rheumatoid arthritis.
• •3. Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.
• •4. The study disease involved neurological symptoms with a BILAG-2004 activity score of class A.
• •Other medical history-related:
• •5. Known primary immunodeficiency (congenital or acquired).
• •6. The subject has uncontrollable active fungal, viral, bacterial or other infections (existing persistent infection-related signs/symptoms, not improved after appropriate anti-infection treatment) or requires intravenous anti-infection drug treatment for infection.
• •7. Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and abnormal peripheral blood hepatitis B virus (HBV) DNA detection (defined as HBV DNA quantification above the normal reference range of the testing center or positive HBV DNA qualitative detection); positive hepatitis C virus (HCV) antibody and positive peripheral blood hepatitis C virus (HCV) RNA; positive Human Immunodeficiency Virus (HIV) antibody; positive cytomegalovirus (CMV) DNA detection; positive Treponema pallidum specific antibody and positive rapid plasma reagin test for syphilis.
• •8. Severe heart disease: including but not limited to unstable angina pectoris and/or myocardial infarction within 12 months of screening, any congestive heart failure (NYHA classification ≥ III), and a history of severe arrhythmia; or left ventricular ejection fraction (LVEF) \< 45%.
• •9. Severe asthma or chronic obstructive pulmonary disease (COPD), with stable treatment considered for mild or moderate asthma or COPD by the investigator and sponsor; or resting arterial blood oxygen saturation \< 91%.
• •10. Evaluated by the investigator as having a severe bleeding risk.
• •11. Evaluated by the investigator as having severe liver dysfunction.
• •12. History of severe kidney disease; or eGFR \< 30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
• •13. Acute cerebrovascular disease events occurred within 6 months before enrollment, including transient ischemic attack or stroke history.
• •14. Any severe and/or uncontrolled comorbid diseases as assessed by the investigator.
• •15. Had a malignant tumor within 5 years before screening, excluding cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical surgery, breast duct carcinoma in situ after radical surgery, or papillary thyroid carcinoma after radical surgery.
• •16. Had a clear history of mental disorder or a history of substance abuse for mental disorders that cannot be quit.
• •17. Known allergy to the components of IASO207 injection or to the supportive drugs required for the toxicity management of CAR-T cell therapy (such as tocilizumab).
• •Previous and concurrent treatments:
• •18. History of organ transplantation.
• •19. History of autologous or allogeneic stem cell transplantation.
• •20. History of cell therapy or CD19-targeted drug treatment.
• •21. Received targeted CD20 biologic therapy within 12 weeks before screening, such as rituximab, obinutuzumab.
• •22. Received plasma exchange or immunoadsorption treatment within 12 weeks before screening.
• •23. Had or planned to have major surgery or surgical treatment caused by any reason within 12 weeks before screening.
• •24. Have participated in the treatment of other investigational drugs (except for placebo) within the previous 4 weeks or 5 half-lives (whichever is longer);
• •25. Have received a BAFF antagonist, such as belimumab or tixagevimab, within the previous 4 weeks;
• •26. Have received live attenuated vaccine within the previous 4 weeks;
• •27. Pregnant or lactating women;
• •28. Other situations deemed unsuitable for inclusion by the investigators.