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NOT YET RECRUITING
NCT07674147
EARLY_PHASE1

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

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

Summary

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).

Official title: A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19/BCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents

Key Details

Gender

All

Age Range

5 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07

Completion Date

2030-07

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

RD06-05 CART Cell Infusion

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Locations (2)

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China