Clinical Study of Recombinant CD19xCD3 Double Antibody (A-319) in the Treatment of Active/Refractory Systemic Lupus Erythematosus
The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).
• Age 18-60 years old, regardless of gender;
• Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
• Active/refractory systemic lupus erythematosus;
• Positive test results for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) immunofluorescence assay at a titer of ≥1:80; anti-dsDNA; or anti-Smith (anti-Sm);
• Receive the standardized and stable treatment for at least 30 days before the first administration of the study drug;
• Female participants tested negative for pregnancy, and participants agreed to use effective contraception throughout the trial;
• Have the ability to understand the nature of the research and voluntarily sign an informed consent form;
• Participants can communicate well with the researchers and complete all visits according to the requirements of the plan.