BiTE antibodies could unlock transplants for 'Incompatible' kidney patients

NCT ID NCT07689149

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This trial is taking on new participants right now.
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Cancelled before anyone took part.

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests two BiTE drugs (blinatumomab and teclistamab) in 20 adults with end-stage kidney disease who have very high antibody levels (cPRA ≥90%) and have waited over 5 years for a transplant. The goal is to safely lower these antibodies enough to make a kidney transplant possible. Participants receive one of the two drugs in a short, low-dose regimen, and researchers track antibody reduction, side effects, and whether transplantation occurs within a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blinatumomab and Teclistamab (BiTE drugs)
What this could lead to
If successful, this approach could help highly sensitized patients receive a kidney transplant by safely reducing harmful antibodies.
What could go wrong
This is a small early-phase trial with only 20 participants. BiTE drugs can cause serious side effects like cytokine release syndrome and neurotoxicity. The treatment may not work for everyone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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