NCT07523282Not yet recruitingPhase 1
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- 31 Dec 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
- NCT number
- NCT07523282
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 31 Dec 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.
- History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.
- Receipt of a live vaccine within 30 days before screening.
Other illness
- Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.
- Presence of any other uncontrolled active infection.
- History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow/hematopoietic stem cell transplantation.
- History of asthma or severe allergy, if considered clinically significant by the investigator.
- Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Adults aged 18 to 69 years, regardless of gender.
- Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.
- Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and/or positive anti-double-stranded DNA antibody, and/or hypocomplementemia.
- Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.