NCT06548620

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

Withdrawn EARLY_PHASE1 Last updated 3 February 2026

What this trial tests

EARLY_PHASE1 trial testing RD06-04 cell infusion in SLE. Withdrawn.

Timeline

31 August 2024

Primary endpoint
31 August 2026

31 August 2027

Quick facts

Lead sponsor	Nanjing Bioheng Biotech Co., Ltd.
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	31 August 2024
Primary completion	31 August 2026
Estimated completion	31 August 2027
Sites	1 location across China

Drugs / interventions tested

• RD06-04 cell infusion — full drug profile →

Conditions studied

• SLE — all drugs for SLE →
• Sclerosis — all drugs for Sclerosis →
• ANCA Associated Vasculitis — all drugs for ANCA Associated Vasculitis →
• IIM — all drugs for IIM →

Sponsor

Nanjing Bioheng Biotech Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with SLE or Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
2. Revolutionizing Autoimmune Kidney Disease Treatment with Chimeric Antigen Receptor-T Cell Therapy.
   Gu R, Shen J, Zhang J, Mao J, et al · · 2025 · cited 7× · PMID 40405911 · DOI 10.34133/research.0712
3. Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
   Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350
4. Roads and detours for CAR T cell therapy in autoimmune diseases.
   Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4
5. CAR T-Cell Immunotherapy in Neuroautoimmune Diseases: Focus on the Central Nervous System
   Demetriou F, Anagnostouli M. · · 2026
6. CAR-T Cell Therapy for Autoimmune Kidney Diseases: Where Do We Stand Now?
   Kaleta B. · · 2025 · PMID 41155362 · DOI 10.3390/ijms262010070