drugset / Trial / NCT07706205

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

NCT07706205

Phase 0 Not yet recruiting 20 enrolled West China Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial was to determine whether the Bites drugs (Blinatumomab and Teclistamab) can reduce blood group antibodies in recipients of living donor blood-incompatible kidney transplants for pretransplant conditioning. It will also understand the safety of Bites drugs in the transplant population. The main questions it aims to answer include: Can Bites effectively reduce blood group antibodies? What are the safety concerns that participants may have when using Bites? Participants will: Be given Blinatumomab and Teclistamab at the standard dose prescribed by the manufacturer before surgery, and blood group antibodies were rechecked every two weeks to two months. The adverse drug reactions and the times of rescue were recorded.

Timeline

Start
2026-09-01
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 9 ug
Subject Teclistamab Monoclonal antibody 1.5 mg/kg