Clinical Study of AFN50 Injection in the Autoimmune Diseases
- Sponsor
- AlphaNa Bioscience Company Limited
- Study ID
- NCT07408336
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 69 Years
- Healthy Volunteers
- Not accepted
Interventions
- AFN50 injection — BIOLOGICALIntravenous infusion therapy. AFN50 was developed using novel T-cell-targeted lipid nanoparticles (T-LNP) encapsulating mRNA encoding Chimeric Antigen Receptor.
Study Details
This is an investigator-initiated trial designed to evaluate the safety, tolerability and primary efficacy of AFN50 injection for the treatment of autoimmune diseases.
Key Dates
- First listed
- Feb 13, 2026
- Start date
- Feb 4, 2026
- Status verified
- Mar 2026
- Primary completion
- Feb 4, 2028
- Completion
- Feb 3, 2029
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Participant GroupAFN50 Injection
Primary Outcome Measure
Adverse events [ Time Frame: 3 months ]
Central Contacts
- Beicheng SUN, Dr+86 551 6292 2800
- Huan ZHOU, Dr+8613665527160
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