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

Recruiting Phase 4 Interventional Study
Antibody Mediated Rejection After Kidney Transplantation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Turun Song · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Functioning living or deceased donor allograft after ≥180 days post-transplantation. 3. eGFR ≥20 ml/min/1.73 m2 (CKD-EPI formula). 4. HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA). 5. Biopsy-confirmed chronic active antibod…
Contacts

Yunfei Xiao, Ph.D

+86 28 85422925

xiaoyunfeix@163.com

CONTACT