HN2302 for Lupus and Systemic Sclerosis, an Early Safety Study
Tests HN2302 injection in adults with lupus or systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT07523282, who can take part
Where in China
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen MagicRNA Biotechnology Co., Ltd
- Trial code
- NCT07523282
- Record updated
- 12 August 2026
- Original description
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).Read full original descriptionShow less
A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases
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).
Inclusion: 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.
Exclusion: 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; 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; Pregnant or breastfeeding women.