Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

Starting soon · Phase 1

Conditions studied: Autoimmune Disease, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)

In brief

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).

Key facts

Study ID

NCT07523282

Run by

Shenzhen MagicRNA Biotechnology Co., Ltd

People needed

12

Starts

2026-04-28

Expected to finish

2028-06-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnant or breastfeeding women.
• 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.
• 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.

Where it is running

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China

Full record on ClinicalTrials.gov

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