A Study of Telitacicept in Lupus Nephritis

Exclusion Criteria

• •1. Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
• •2. History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
• •3. Received any of the following therapies:
• •1. Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;
• •2. Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
• •3. Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
• •4. Received plasma separation or plasma exchange during the 6 weeks prior to screening;
• •5. Subjects who required dialysis within 1 year prior to screening.
• •6. Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
• •7. Received BCG Vaccine within 1 year prior to screening.
• •4. History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1).
• •5. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
• •6. Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
• •7. Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
• •8. History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
• •9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.
• •10. History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
• •11. Have acute or chronic infection requiring treatment.
• •12. HIV positive.
• •13. Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll.
• •14. Hepatitis C antibody positive.
• •15. History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.
• •16. eGFR\<30 mL/min/1.73 m2 using CKD-EPI.
• •17. Renal biopsy showed 50% glomerulosclerosis.
• •18. Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables.
• •19. Subjects who in the opinion of the investigator are not suitable to participate.