Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)

Exclusion Criteria

• •Subjects who are pregnant or lactating, or who plan to have a child in the 12 months prior to the first dosing.
• •Severe lupus nephritis within 30 days prior to initial administration;
• •Central nervous system diseases caused by SLE or not caused by SLE in the 12 months before the first dose;
• •Current or past autoimmune diseases other than SLE
• •There is an active and uncontrolled infection, or an infection that has recently required intravenous anti-infective therapy, or is currently being treated for any chronic infection
• •Subjects whose chest radiology within 6 months prior to screening indicates active tuberculosis
• •Have active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) RNA positive; Or a history of human immunodeficiency virus (HIV) infection, or a positive HIV serological result at screening; The specific antibody of Treponema pallidum was positive and the confirmatory test was positive. If HBV core antibody is positive but HBV-DNA is negative, HBV-DNA should be monitored once every 3 months.
• •Herpes or shingles infection, or a history of disseminated/complicated shingles in the 12 weeks prior to screening;
• •Cardiovascular and cerebrovascular abnormalities;
• •Have a lung disease that the investigator determines is not suitable for participation in the study
• •Subjects with a history or suspected demyelinating disease of the central nervous system;
• •Subjects with a history of or suspected demyelinating disease of the central nervous system;
• •Subjects with any type of active malignancy or with a history of malignancy;
• •Have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
• •The subject has any medical condition that may affect the absorption of oral medications (e.g., bariatric/obesity surgery, or the subject is unable to take oral medications;
• •Previous use of specific drugs;
• •Patients who underwent plasma replacement within 12 weeks prior to initial administration or treated with human immunoglobulin 4 weeks prior to initial administration;
• •Cyclophosphamide had been used within 3 months before the first dose;
• •Rituximab or any other B-cell depletion therapy within 6 months prior to initial administration;
• •Use Beliuzumab, Taitacept, tumor necrosis factor (TNF) antagonists, or other biologics before initial administration unless the elution time is met, as specified in Appendix 17;
• •Participants who have suffered a major trauma, fracture, or surgical procedure in the 4 weeks prior to screening, or who are expected to require major surgical procedures during the study period;
• •Participants who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period.