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
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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