Shanghai Aidisheng Biotechnology Co., Ltd.

The main objective of this study, Part 1, is to evaluate the safety characteristics of ADI-001 in three types of patients and determine its MTD/MAD to provide a basis for subsequent dose expansion studies (Part 2). Part 2: Aims to further characterize the safety characteristics of ADI-001 at the MTD/MAD levels determined in Part 1 in subjects with LN and SLE with extrarenal involvement (Cohort 1), SSc subjects (Cohort 2), and AAV subjects (Cohort 3), and confirm the RP2D of subsequent studies. Secondary objectives include: evaluating the cell dynamics of ADI-001 in each cohort, determining the preliminary efficacy in each cohort, evaluating the host B cell dynamics after ADI-001 administration in Cohort 1, and evaluating the dynamics of other host immune cells after ADI-001 administration. Exploratory studies are intended to: evaluate the relationship between pharmacodynamic biomarkers and toxicity and response; evaluate the association of safety biomarkers with dose and/or response; and evaluate the immunogenicity of ADI-001. Responses were assessed according to SLEDAI-2K and DORIS criteria in cohort 1; other efficacy measures of ADI-001 in SSc and AAV were characterized in cohorts 2 and 3.