Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation

Inclusion criteria

• Age ≥18 years old and ≤65 years old, regardless of gender
• End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months
• Plan to receive ABO-incompatible living donor kidney transplantation (ABOi-LDKT), and the matching has been approved by the organ transplantation ethics committee and technical committee of the hospital
• Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)
• able to understand study procedures, provide written informed consent, and be willing and able to comply with the study visit schedule and laboratory examination requirements

Exclusion criteria

• patients allergic to the components of rituximab, teritumumab and berintuomab;
• Hematologic diseases or myelosuppression (ANC < 1.0×10⁹/L, PLT < 75×10⁹/L);
• multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;
• acute active infection (including HBV, HCV, HIV, uncontrolled bacterial/fungal infection);
• Severe cardiac dysfunction (NYHA class III-IV)
• known or suspected hereditary complement deficiency
• abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) > 3 times the upper limit of normal (ULN); Or alkaline phosphatase (ALP) or total bilirubin values greater than 1.5 times the upper limit of normal (ULN).
• Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.
• complicated with other uncontrolled malignant tumors;
• women who are pregnant, breastfeeding or planning to become pregnant;
• patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;
• Patients who were not eligible for the study for other reasons according to the investigator's judgment.