Exploratory Study on mRNA Therapy Targeting CD19 for the Treatment of Refractory Autoimmune Diseases

Exclusion Criteria

• •1\) Study participants who are allergic or hypersensitive to any component of the investigational drug, including those who are allergic to messenger RNA (mRNA) vaccines or other RNA LNP products.
• •2\) Merge any active infections that require antibiotic treatment and have not been controlled for at least one week prior to D1 administration.
• •3\) Malignant tumors diagnosed within the first 2 years of screening are excluded, except for skin basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ that has been adequately treated.
• •4\) Uncontrolled ischemic heart disease, including unstable angina within the previous 6 months of screening, or evidence of active ischemic heart disease on electrocardiogram.
• •5\) New York Heart Association (NYHA) grade III-IV heart failure.
• •6\) Study participants with combined active hepatitis B virus (HBV) infection \[defined as surface antigen (HBsAg) positive and HBV DNA positive (detected by PCR)\].
• •7\) Study participants with combined active hepatitis C virus (HCV) infection (defined as HCV RNA positive (detected by PCR), regardless of anti HCV antibody status).
• •8\) Human immunodeficiency virus (HIV) infection or history of HIV infection.
• •9\) Study participants who tested positive for Treponema pallidum specific antibodies.
• •10\) There may be active infection of Mycobacterium tuberculosis.
• •11\) Women who are currently pregnant, breastfeeding, or planning to become pregnant.
• •12\) Combining severe or recently (\<2 months) diagnosed medical conditions, as determined by the researchers, may affect the study participants' tolerance to the study drug or their ability to complete the study process.
• •13\) Received attenuated live vaccine or protein subunit vaccine within 30 days prior to the first study medication.