Kidney Transplant Recipients with Chronic Active Antibody-Mediated Rejection (cAMR)
Conditions
Interventions
Bispecific T cell engager treatment group:BiTE (BCMA x CD3 Bispecific Antibody)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.>= 180 days after allogeneic kidney transplantation; 3.Presence of detectable donor-specific antibodies (DSA) with mean fluorescence intensity (MFI) > 1000 (i.e., DSA-positive); 4.Biopsy-confirmed chronic active antibody-mediated rejection (cAMR) according to the Banff 2019 criteria; 5.Voluntarily signed informed consent, with willingness and ability to adhere to regular follow-up and complete collection of all study-related information;
Exclusion criteria
Exclusion criteria: 1. Age 3 × upper limit of normal (ULN); or alkaline phosphatase (ALP) or total bilirubin >1.5 × ULN; 9. Central nervous system (CNS) disorders, including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or CNS vasculitis, visual disturbances, cranial neuropathy requiring intervention, etc.; 10. Concurrent uncontrolled malignancy; 11. Pregnancy, lactation, or planned pregnancy during the study period; 12. Poor pre- or post-operative compliance, or inability to cooperate with treatment and study procedures due to psychiatric or other medical conditions; 13. Other conditions that, in the investigator's judgment, make the patient unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ferritin quantification;coagulation profile;serum electrolytes;complete blood count;serum hepatic and renal function panel;C reactive protein (CRP) assay;a panel of cytokines;interleukin 6;Immunoglobulin quantification;urinalysis;Neuropsychiatric safety and quality of life follow up; | — |
Secondary
| Measure | Time frame |
|---|---|
| B cell subsets;HLA class I antibody detection;Pathological analysis of renal allograft biopsy;24 hour urine protein,urine protein to creatinine ratio,urine albumin to creatinine ratio;TBNK;HLA class II antibody detection;Donor derived cell free DNA;T cell activation and memory subsets;Ultrasound of the renal allograft; | — |
Countries
China
Contacts
Public ContactTurun Song
West China Hospital of Sichuan University
Outcome results
None listed