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NOT YET RECRUITING
NCT07689578
PHASE4

Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant Recipients With Chronic Active Antibody-Mediated Rejection

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07

Completion Date

2029-12-31

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

BiTE (BCMA x CD3 Bispecific Antibody)

Subcutaneous administration of BCMA x CD3 Bispecific Antibody