Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%

Starting soon · Phase 4

Conditions studied: Kidney Transplantation Recipients, HLA Sensitization

In brief

This study is a prospective, open-label, two-arm exploratory clinical trial aimed at evaluating the safety and efficacy of Bispecific T-cell Engager (BiTE) therapies in refractory, highly sensitized kidney transplant candidates. Patients with end-stage renal disease (ESRD) who have a calculated panel reactive antibody (cPRA) ≥ 90% and have waited for a transplant for over 5 years, despite receiving standard desensitization therapies (e.g., IVIG, plasmapheresis, rituximab), will be enrolled. A total of 20 participants will be randomized in a 1:1 ratio to receive either Blinatumomab (a CD19×CD3 BiTE) or Teclistamab (a BCMA×CD3 BiTE). The primary objective is to evaluate the desensitization response rate, defined as the reduction of cPRA to \< 20% or by ≥ 50% from baseline, assessed at multiple time points up to 1 year post-treatment. Secondary objectives include assessing the safety profile (such as the incidence of Cytokine Release Syndrome \[CRS\] and neurotoxicity), the extent of CD19+ B cell depletion, and the proportion of participants who successfully undergo kidney transplantation within 1 year.

Key facts

Study ID

NCT07689149

Run by

West China Hospital

People needed

20

Starts

2026-06-30

Expected to finish

2029-12-31

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants aged 18 to 65 years.
• Diagnosis of end-stage kidney disease and being evaluated for or awaiting kidney transplantation.
• Calculated panel-reactive antibody level (cPRA) ≥90% and a kidney transplant waiting time of ≥5 years.
• Previous treatment with a conventional desensitization regimen based on intravenous immunoglobulin and/or plasma exchange, with or without rituximab, with traceable medical records.
• Persistent cPRA ≥90% or unacceptable HLA antibodies after conventional desensitization, resulting in failure to meet the immunological criteria for kidney transplantation.
• Adequate nonrenal organ function to tolerate the study treatment, including left ventricular ejection fraction >50%, resting oxygen saturation >94%, AST and ALT <3 times the upper limit of normal, total bilirubin <34.2 μmol/L, and no active infection.
• Ability to understand the study procedures, provide written informed consent, and comply with study treatment and follow-up requirements.

You may not qualify if…

• Inability to understand or comply with the study protocol or follow-up schedule.
• Known or suspected hereditary complement deficiency.
• Clinically significant central nervous system disease, including epilepsy, psychotic disorder, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, or cranial neuropathy requiring intervention.
• AST, ALT, or GGT >3 times the upper limit of normal, or alkaline phosphatase or total bilirubin >1.5 times the upper limit of normal.
• Acute myocardial infarction or unstable angina within 6 months before screening, severe cardiac arrhythmia, or New York Heart Association class III or IV heart failure.
• Uncontrolled acute or chronic disease unrelated to end-stage kidney disease that may impair tolerance to study treatment.
• Active or uncontrolled infection requiring systemic treatment.
• Human immunodeficiency virus infection or uncontrolled active hepatitis B or hepatitis C infection.
• Participation in another interventional clinical study within 3 months before screening or planned concurrent participation in another interventional study.
• Previous treatment with another T-cell engager or bispecific T-cell-redirecting therapy.
• Known severe hypersensitivity to blinatumomab, teclistamab, or any of their excipients.
• Active malignancy.
• Pregnancy, breastfeeding, or planned pregnancy during the study period.
• Previous bone marrow transplantation, hematopoietic stem cell transplantation, or solid-organ transplantation other than kidney transplantation.
• Receipt of a live vaccine within 30 days before screening or planned receipt of a live vaccine during study treatment.
• Any other clinically significant condition that, in the investigator's judgment, may increase participant risk, interfere with study procedures, or affect safety or efficacy assessments.

Full record on ClinicalTrials.gov

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