A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Systemic Lupus Erythematosus

Exclusion Criteria

• •1. Severe lupus nephritis within 8 weeks before screening;
• •2. She had uncontrolled lupus crisis within 8 weeks before screening and was not suitable for the study as assessed by the investigator;
• •3. Active encephalopathy or psychosis within 6 months before screening;
• •4. Primary diagnosis of different autoimmune or inflammatory diseases;
• •5. B cell-depleting therapy within 6 months before initiation of GNC-038 treatment;
• •6. Received CAR-T therapy within 6 months before GNC-038 treatment;
• •7. Cytokine-targeting biologic agents used within 12 weeks before dose administration;
• •8. Use of anti-tumor necrosis factor drugs within 8 weeks before administration;
• •9. Use of any JAK inhibitor within 2 weeks before dosing;
• •10. Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;
• •11. Major organ transplantation history or hematopoietic stem cell/bone marrow transplantation;
• •12. Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;
• •13. A history of any cardiovascular disease described in the protocol within 6 months before screening;
• •14. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
• •15. Prolonged QT interval at rest (QTcf \> 450 msec in men or \> 470 msec in women);
• •16. A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;
• •17. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;
• •18. Women who are pregnant or breastfeeding;
• •19. Have a history or evidence of suicidal thoughts within 6 months before signing ICF, which is considered by the researcher to be a significant risk of suicide;
• •20. Diagnosed with malignant tumor within 5 years before signing ICF;
• •21. Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;
• •22. History of splenectomy;
• •23. Investigators considered a history of alcohol or drug abuse in the 12 months before screening;
• •24. Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;
• •25. A history of severe and/or disseminated viral infection;
• •26. Active M. tuberculosis infection may be present.