This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.
The CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells/kg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.
General Inclusion Criteria (All Patients)
Voluntarily provides written informed consent.
Age ≥18 and ≤70 years, any gender.
ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).
Coexisting autoimmune disease confounding disease activity/safety (stable ≥3 months may be eligible with approval).
Anti-CD20 mAb/T-cell engager within 3 months; CD19/BCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell > LLN and approval).
Rapidly progressive glomerulonephritis (RPGN).
NYHA III/IV heart failure; severe cardiac disease within 12 months.
Nanjing Bioheng Biotech Co., Ltd.
Lead sponsor