Actively Recruiting
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
Led by Shenzhen MagicRNA Biotechnology Co., Ltd · Updated on 2026-04-28
30
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
S
Shenzhen MagicRNA Biotechnology Co., Ltd
Lead Sponsor
T
The First Affiliated Hospital of University of Science and Technology of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
CONDITIONS
Official Title
Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 69 (inclusive), of any gender
- Appropriate bone marrow function: ANC 51.5�d7 10^9/L, ALC 50.8�d7 10^9/L, Hb 580g/L without recent transfusions or growth factors
- Coagulation function: INR or APTT 41.5�d7 upper limit of normal
- Cardiac function: left ventricular ejection fraction (LVEF) 540% by echocardiography
- Lung function: no more than grade 1 dyspnea and oxygen saturation 592% on room air
- Liver function: ALT and AST 42.5�d7 upper limit of normal, total bilirubin below 2.0 mg/dL (or below 3.0 mg/dL for Gilbert syndrome)
- Kidney function: creatinine clearance 550 mL/min without fluid assistance
- Non-pregnant and non-lactating, willing to use contraception for 12 months after treatment
- Diagnosed with SLE per 2019 criteria, with stable treatment for at least 8 weeks
- SSc patients meeting classification criteria with mRSS score between 10 and 35
- RA patients meeting classification criteria with DAS28-ESR > 3.2 and positive ACPA
You will not qualify if you...
- Positive for Hepatitis B surface antigen, core antibody, or detectable HBV DNA
- Positive for Hepatitis C virus antibodies or detectable HCV RNA
- Positive for HIV antibodies or CMV DNA
- Positive for syphilis antigen or antibodies
- Active uncontrolled infections
- History of major organ or bone marrow transplantation
- Pregnant or breastfeeding
- Received mRNA-LNP or other LNP medications within the past two years
- Cardiovascular disease within last 6 months including severe heart failure, myocardial infarction, unstable angina, or arrhythmias
- Received live vaccine in last 30 days
- Asthma or severe allergies
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Actively Recruiting
Research Team
Z
Zhu Chen, MD
CONTACT
Z
Ze Xiu Xiao, MD
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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