Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%

Inclusion Criteria: * Male or female participants aged 18 to 65 years. * Diagnosis of end-stage kidney disease and being evaluated for or awaiting kidney transplantation. * Calculated panel-reactive antibody level (cPRA) ≥90% and a kidney transplant waiting time of ≥5 years. * Previous treatment with a conventional desensitization regimen based on intravenous immunoglobulin and/or plasma exchange, with or without rituximab, with traceable medical records. * Persistent cPRA ≥90% or unacceptable HLA antibodies after conventional desensitization, resulting in failure to meet the immunological criteria for kidney transplantation. * Adequate nonrenal organ function to tolerate the study treatment, including left ventricular ejection fraction \>50%, resting oxygen saturation \>94%, AST and ALT \<3 times the upper limit of normal, total bilirubin \<34.2 μmol/L, and no active infection. * Ability to understand the study procedures, provide written informed consent, and comply with study treatment and follow-up requirements. Exclusion Criteria: * Inability to understand or comply with the study protocol or follow-up schedule. * Known or suspected hereditary complement deficiency. * Clinically significant central nervous system disease, including epilepsy, psychotic disorder, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, or cranial neuropathy requiring intervention. * AST, ALT, or GGT \>3 times the upper limit of normal, or alkali…