Actively Recruiting
Dose-Escalation Study to Assess Safety, Tolerability, and Preliminary Efficacy of HN2301 Injection in Autoimmune Diseases Including Lupus, Systemic Sclerosis, and Rheumatoid Arthritis
Led by Shenzhen MagicRNA Biotechnology Co., Ltd · Updated on 2026-04-28
30
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the safety and preliminary effectiveness of HN2301 injection in adults with autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), and Rheumatoid Arthritis (RA). This is an open-label, single-arm Phase 1 study designed to explore how HN2301 affects these conditions and monitor its safety profile. Participants will receive HN2301 injections starting at a low dose, with potential dose increases based on safety and study guidelines. The treatment is given according to specified days and dose levels throughout the study. This trial involves one treatment group receiving HN2301, and dosing is carefully controlled and monitored. Throughout the study, participants will undergo assessments including blood tests to monitor immune cells, disease activity scores like SLEDAI-2K and DAS28, skin scoring for SSc, and patient-reported outcomes for up to 12 months. Researchers will track any treatment-related side effects for up to 3 months and evaluate various measures of disease activity and response. The total study duration includes these follow-ups to observe changes over time.
CONDITIONS
Brief 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 years, any gender
- Adequate bone marrow function: ANC ≥1.5×10^9/L, ALC ≥0.8×10^9/L, hemoglobin ≥80 g/L without recent transfusions or growth factors
- Coagulation function: INR or APTT ≤1.5× ULN
- Cardiac function: Left ventricular ejection fraction ≥40% by echocardiography
- Lung function: Dyspnea CTCAE grade ≤1 and oxygen saturation ≥92% on room air
- Liver function: ALT and AST ≤2.5× ULN, total bilirubin <2.0 mg/dL (or <3.0 mg/dL for Gilbert syndrome)
- Kidney function: Creatinine clearance ≥50 mL/min without fluid assistance
- Non-pregnant, non-lactating and willing to use contraception for 12 months after infusion
- Diagnosed with SLE (per 2019 EULAR/ACR criteria) with stable treatment for at least 8 weeks and positive ANA, anti-dsDNA antibodies, or hypocomplementemia
- Classified SSc patients with mRSS score between 10 and 35
- Classified RA patients with DAS28-ESR >3.2 and positive ACPA
You will not qualify if you...
- Positive for Hepatitis B surface antigen, core antibody, or HBV DNA above detection limits
- Positive for Hepatitis C antibodies and HCV RNA above detection limits
- Positive for HIV antibodies, CMV DNA, or syphilis antigen/antibodies
- Active uncontrolled infections
- History of major organ or bone marrow transplantation
- Pregnant or breastfeeding women
- Use of mRNA-LNP or other lipid nanoparticle medications within past 2 years
- Recent cardiovascular diseases within 6 months such as severe heart failure, myocardial infarction, unstable angina, or significant arrhythmias
- Receipt of live vaccines within 30 days
- Asthma or severe allergies
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive HN2301 injection at specified dose levels with possible dose escalation to evaluate safety and efficacy in autoimmune diseases.
Multiple visits during dosing period
Duration - Up to 12 months
Participants are monitored for safety and efficacy outcomes for up to 12 months after treatment.
Regular visits for assessments during follow-up
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
Z
Ze Xiu Xiao, MD
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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