A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases

NCT07448298 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Autoimmune Diseases

Interventions

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.

Sponsors & Collaborators

  • Beijing Boren Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448298 on ClinicalTrials.gov