Clinical Research Directory

Inclusion Criteria: 1. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. No gender limit; 3. Age: ≥18 years old and ≤75 years old; 4. Life expectancy greater than 6 months; 5. SLE was diagnosed according to the 2019 EULAR/ACR revised criteria; 6. Patients with moderate to severe systemic lupus erythematosus, SLEDAI-2K score \&gt at screening; 7 points; 7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose; 8. ANA ≥ 1:80 or anti-dsdna antibody higher than the upper limit of normal range (ULN) as determined by central laboratory at screening; 9. The presence of CD19+ B cells in the peripheral blood of the patient; 10. The organ function level before the first administration met the requirements; 11. Female subjects of childbearing potential or male subjects with a fertile partner must use highly effective contraception from 7 days before the first dose until 24 weeks after the termination of treatment and should commit not to donate eggs (eggs, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose; 12. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. 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.