RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases

This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus/lupus nephritis (SLE/LN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN). Approximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells/kg, with a potential dose escalation to 10×10⁶ CAR+ T cells/kg following review by a Safety Review Committee (SRC).

NCT Number	NCT07674147
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine
Conditions	Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, IgAN - IgA Nephropathy, Multi-Drug Resistant Nephrotic Syndrome
Enrollment	30 participants
Start Date	2026-07
Primary Completion	2029-07 (estimated)
Study Completion	2030-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-29