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.
Single group
RD06-05 CAR-T Cell Injection
DrugCAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
SLE (systemic lupus erythematosus)
Proportion of patients achieving lupus low disease activity state (LLDAS) and DORIS(Definition Of Remission In SLE) remission, as well as the proportion of patients achieving drug-free remission
SLE (systemic lupus erythematosus)
Proportion of SLE patients with renal involvement who achieved complete renal response (CRR) and partial renal response
SLE (systemic lupus erythematosus)
Change in UPCR(Urine Protein/Creatinine Ratio) from baseline in SLE patients with renal involvement
SLE (systemic lupus erythematosus)
Change in eGFR(estimated Glomerular Filtration Rate) from baseline in SLE patients with renal involvement
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