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

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).

The study consists of a screening period of up to 4 weeks, a treatment period, and a follow-up period of 1 year.

Inclusion Criteria:

• 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 Criteria:

• 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.