CHT105 for the Treatment of Refractory Lupus Nephritis

Exclusion criteria

• ✕. Individuals with a history of severe drug allergy or allergic constitution;
• ✕. Presence of, or suspicion of, uncontrolled fungal, bacterial, viral, or other infections requiring hospitalization or intravenous therapy within one month prior to baseline;
• ✕. Any of the following cardiovascular or cerebrovascular events within six months prior to screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic coronary angiography is permitted), moderate-to-severe congestive heart failure (NYHA Class III or IV), atrial or ventricular arrhythmias requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia), implantation of a pacemaker or defibrillator, cerebrovascular accident (e.g., stroke), or planned coronary artery bypass surgery or vascular reconstruction during the trial;
• ✕. Participants with congenital immunoglobulin deficiency;
• ✕. History of malignancy within the past five years (except for basal cell carcinoma, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ, or thyroid carcinoma, all of which must have been definitively cured for at least one year);
• ✕. Participants with end-stage renal failure;
• ✕. Active tuberculosis risk at screening, regardless of whether adequate treatment has been completed-including signs or symptoms of active tuberculosis as judged by the investigator at screening (e.g., fever, cough, night sweats, weight loss); or evidence of active pulmonary tuberculosis on chest imaging (e.g., chest X-ray or chest CT scan) performed at screening or at any time within six months prior to screening;
• ✕. Participants who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb), with peripheral blood HBV DNA levels exceeding the upper limit of quantification; participants who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; participants who are positive for human immunodeficiency virus (HIV) antibody; or participants with a positive syphilis test;