Actively Recruiting
Clinical Study of AFN50 Injection in the Autoimmune Diseases
Led by AlphaNa Bioscience Company Limited · Updated on 2026-03-05
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
AlphaNa Bioscience Company Limited
Lead Sponsor
T
The First Affiliated Hospital of Anhui Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator-initiated trial designed to evaluate the safety, tolerability and primary efficacy of AFN50 injection for the treatment of autoimmune diseases.
CONDITIONS
Official Title
Clinical Study of AFN50 Injection in the Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Aged between 18 and 69 years, any gender
- Diagnosed with systemic lupus erythematosus (SLE) according to 2019 EULAR/ACR criteria
- History of SLE for at least 6 months and stable standard treatment for at least 8 weeks with stable dosage for 2 weeks
- Disease remains active or has relapsed despite treatment with NSAIDs, antimalarials, corticosteroids, immunosuppressants, or targeted drugs
- Oral corticosteroid dose between 7.5 mg/day and 30 mg/day prednisone (or equivalent); no minimum dose if combined with immunosuppressants
- Failure of standardized treatment with hydroxychloroquine or at least two immunosuppressants
- Positive blood antinuclear antibody (ANA), and/or positive anti-double-stranded DNA antibodies, and/or low complement (C3 and/or C4)
- SLEDAI-2K score of 6 or higher, with clinical symptoms score of 4 or higher if including low complement or anti-dsDNA antibodies
- Adequate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions within specified laboratory ranges
- Baseline oxygen saturation above 92% without oxygen support
- Non-pregnant, non-lactating; women of childbearing potential must have a negative pregnancy test and agree to contraception for 12 months post-infusion
You will not qualify if you...
- Positive hepatitis B surface antigen or core antibody with detectable hepatitis B DNA, positive hepatitis C antibodies and RNA, positive HIV antibodies, positive CMV DNA, or positive syphilis antigen or antibodies
- Presence of uncontrolled active infections
- History of major organ transplantation or bone marrow/hematopoietic stem cell transplantation
- Use of mRNA-LNP products or lipid nanoparticle medications within past two years or allergy to these components
- Live vaccine administration within the last 30 days
- Cardiovascular diseases within last 6 months including severe heart failure, myocardial infarction, unstable angina, significant arrhythmias, or other serious heart conditions
- Pregnant or breastfeeding women
- Asthma or severe allergies
- Unlikely to complete all study visits or follow-up as judged by investigator
- Other conditions deemed inappropriate for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
B
Beicheng SUN, Dr
CONTACT
H
Huan ZHOU, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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