NCT06548620

A Study of RD06-04 in Patients With Active Autoimmune Diseases

Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CD19-targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases Mediated by Autoantibodies.

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nanjing Bioheng Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).

Conditions

• SLE
• Sclerosis
• ANCA Associated Vasculitis
• IIM
• SS
• MS
• NMO Spectrum Disorder
• MG

Interventions

Type	Name	Description
DRUG	RD06-04 cell infusion	CAR T Cells

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2024-08-12
• Last updated: 2026-02-03

Locations

1 site across 1 country: China