Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

Inclusion Criteria:

• Patients aged between 18 and 69 (inclusive), of any gender;

• Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions.Bone marrow function: ANC ≥1.5×10^9/L, ALC ≥0.8×10^9/L, Hb ≥80g/L. No use oftransfusions and growth factors allowed within 7 days prior to screening to meetthese requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function:Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulseoximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, totalbilirubin <2.0mg/dL (Gilbert syndrome subjects total bilirubin <3.0mg/dL). Kidneyfunction: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL/min withoutneed for fluid assistance;

• Non-pregnant/non-lactating participants, willing to adopt contraceptive measureswithin 12 months after drug infusion;

• Diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria; Ahistory of SLE for at least 6 months, having used a stable standard treatmentregimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalentdrug) ≥7.5mg/day and ≤30mg/day. At least two immunosuppressants have been used in astandardized manner (including hydroxychloroquine); Screening period tests meet:positive blood antinuclear antibody (ANA), and/or positive anti-ds-DNA antibodies,and/or hypocomplementemia;

• SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;

• RA-meets the classification criteria of ACR and EULAR, DAS28-ESR>3.2, ACPApossitive.

Exclusion Criteria:

• Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis Bcore antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers abovethe detection threshold; those with positive Hepatitis C virus (HCV) antibodies andHCV RNA positivity or titers above the detection threshold; individuals with HumanImmunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above thedetection limit; those with positive syphilis antigen or antibodies;

• Presence of other uncontrolled active infections;

• History of major organ transplantation (such as heart, lung, liver, kidney) or bonemarrow/hematopoietic stem cell transplantation;

• Pregnant or breastfeeding women;

• Receiving any mRNA-LNP product or other LNP medications within the past two years;

• History of any of the following cardiovascular diseases within the last 6 monthsbefore screening: Class III or IV heart failure defined by the New York HeartAssociation (NYHA), myocardial infarction, unstable angina, uncontrolled orsymptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinicallysignificant cardiac diseases;

• History of live vaccine administration within the last 30 days;

• Individuals with asthma, severe allergies;

• Other conditions deemed inappropriate for participation in this clinical study bythe investigator.