Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus

Exclusion Criteria

• •Known hypersensitivity to monoclonal antibodies, immunoglobulins, or any component of the study drug.
• •Prior treatment with B cell-depleting therapies, B cell-targeting biologics, or other biologic or targeted therapies within protocol-defined washout periods.
• •Receipt of intravenous immunoglobulin or plasma exchange within protocol-defined washout periods.
• •Receipt of live or attenuated vaccines within 4 weeks prior to enrollment.
• •Presence of other active autoimmune diseases or inflammatory conditions (except secondary Sjögren's syndrome) that may interfere with assessment of SLE disease activity.
• •History of major organ transplantation.
• •History of malignancy within the past 5 years (except adequately treated low-risk cancers).
• •Clinically significant or uncontrolled cardiovascular, cerebrovascular, neurological, hepatic, renal, hematologic, or metabolic diseases.
• •Active or uncontrolled infections, including tuberculosis (active or untreated latent), hepatitis B or C, human immunodeficiency virus (HIV), or other clinically significant infections.
• •Active or severe neuropsychiatric conditions that may interfere with study participation.
• •Uncontrolled hypertension or clinically significant electrocardiogram abnormalities (including prolonged QT interval).
• •Clinically significant abnormal laboratory findings at screening (e.g., severe cytopenias, impaired liver or renal function, or coagulation abnormalities).
• •Recent major surgery or planned surgery during the study period.
• •Recent use of investigational agents or participation in another clinical study within 4 weeks prior to enrollment.
• •Pregnant or breastfeeding women, or women of childbearing potential unwilling to use effective contraception during the study and for an appropriate period after the last dose.
• •Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.