Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical Collaboration (SLICC) criteria.
Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have been dose stable for >2 weeks, with the disease remaining active (i.e., prior glucocorticoid + immunosuppressant or glucocorticoid + immunosuppressant + biologics, any of the above medications alone do not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day; 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for corticosteroids.
positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening.
Screening Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >6 and 'clinical' SLEDAI-2K score ≥4.
Combination of other autoimmune diseases requiring systemic therapy.
SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe neuropsychiatric lupus, severe haemolytic anaemia, severe immune thrombocytopenia, granulocyte deficiency, severe cardiac damage, severe lupus pneumonitis, severe lupus hepatitis, severe vasculitis, etc., which were assessed as unsuitable for participation in the study by the investigator.
Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not limited to: cerebral vascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndromes, or psychosis.
History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for such transplantation.