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.
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