Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

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 yea…