Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant Recipients With Chronic Active Antibody-Mediated Rejection
This clinical trial aims to determine whether a bispecific T-cell engager (BiTE) targeting BCMA×CD3 effectively treats chronic active antibody-mediated rejection (cAMR) in kidney transplant recipients. The study also investigates the safety of BiTE in this patient population. The main questions it aims to answer are: 1. Is BiTE safe and tolerable in kidney transplant recipients with cAMR? 2. Can BiTE improve cAMR? (i.e., can it reduce donor-specific antibody levels, ameliorate histological injury on transplant biopsy, and stabilize or improve kidney function by depleting pathogenic B cells and plasma cells?) Researchers will evaluate the effects of BiTE by comparing clinical outcomes before and after treatment in all participants, as this is a single-arm study (all participants receive the same treatment).
• Age ≥18 years.
• Functioning living or deceased donor allograft after ≥180 days post-transplantation.
• eGFR ≥20 ml/min/1.73 m2 (CKD-EPI formula).
• HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
• Biopsy-confirmed chronic active antibody-mediated rejection (cAMR) according to the Banff 2019 criteria.
• Voluntarily signed informed consent, with willingness and ability to adhere to regular follow-up and complete collection of all study-related information.