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. Patients diagnosed with rheumatoid arthritis according to 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria; 6. Patients were moderately to severely active RA at the time of screening; 7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose; 8. Previous treatment with antirheumatic drugs other than MTX: Leflunomide should be discontinued at least 8 weeks before the start of study treatment or cholestyramine should be used for 14 days; 9. Erythrocyte sedimentation rate (ESR) \> 28mm/hr or C-reactive protein (CRP) \> 10mg/L; 10. Positive rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies; 11. There were CD19+ B cells in the peripheral blood of the patient; 12. Diagnosis of rheumatoid arthritis (RA) more than 6 months; 13. The organ function level before the first administration met the requirements; 14. Fertile female subjects or male subjects with fertile partners 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; 15. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Confirmed diagnosis of another autoimmune rheumatic disease; 2. B cell-targeted therapy agents administered within 6 months before GNC-038 treatment; 3. Received CAR-T therapy within 6 months before GNC-038 treatment; 4. Use of anti-TNF drugs within 8 weeks before administration; 5. Use of any JAK inhibitor within 2 weeks before dosing; 6. Antimalarial drugs, sulfasalazine, penicillamine, etc. were used within 4 weeks before the drug administration; 7. Use of phytochemicals within 4 weeks before administration; 8. The use of other biological agents or other non-B cell depleting clinical investigational drugs before drug administration did not exceed 5 half-lives; 9. Received an intra-articular injection within 4 weeks before study entry; 10. Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug; 11. ACR functional class IV or bedridden/wheelchair-bound; 12. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation; 13. Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection; 14. A history of any cardiovascular disease described in the protocol within 6 months before screening; 15. Poorly controlled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg); 16. Prolonged QT interval at rest (QTcf \> 450 msec in men or \> 470 msec in women); 17. A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy; 18. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038; 19. Women who are pregnant or breastfeeding; 20. Having 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; 21. Diagnosed with malignant tumor within 5 years before signing ICF; 22. Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator; 23. History of splenectomy; 24. Investigators considered a history of alcohol or drug abuse in the 12 months before screening; 25. Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening; 26. A history of severe and/or disseminated viral infection; 27. Active M. tuberculosis infection may be present.