NCT07448298

A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, single-centre exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of AFN50 Injection in adult patients with B-cell-mediated refractory/replapased autoimmune diseases.

Detailed description

The study employs a "3+3" dose-escalation design with a total of 9-18 subjects enrolled. The objective is to evaluate the safety, tolerability, and primary efficacy of AFN50 injection in relapsing and refractory autoimmune disease. The primary endpoint is the incidence and severity of treatment-related adverse events, with a total follow-up period of approximately 24 months.

Conditions

• Relapsed/Refractory Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	AFN50 injection	Intravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) that encapsulate RNA encoding a Chimeric Antigen Receptor.

Timeline

• Start date: 2026-03-09
• Primary completion: 2028-02-29
• Completion: 2029-02-28
• First posted: 2026-03-04
• Last updated: 2026-03-11

Locations

1 site across 1 country: China