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

Korábbi kezelés

• 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.
• 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.

Más betegség

• Known hypersensitivity to monoclonal antibodies, immunoglobulins, or any component of the study drug.
• 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.
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Laborértékek

• 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).

Egyéb

• 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.

• Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with active disease defined as SLEDAI-2K ≥6 at screening, and considered to have inadequate response, intolerance, or ineligibility to standard therapy.
• Have received standard therapy for SLE for at least 12 weeks prior to screening (including corticosteroids and at least one immunosuppressant and/or biologic agent), or are intolerant to or unsuitable for such therapies.
• Receiving stable background therapy prior to enrollment, including stable doses of corticosteroids (within 2 weeks prior to enrollment), and/or antimalarial agents or one immunosuppressant (within 4 weeks prior to enrollment).
• Positive for at least one lupus-related autoantibody at screening (e.g., anti-dsDNA, antinuclear antibody, or anti-Smith antibody).
• Able and willing to provide written informed consent and comply with study procedures.