Immune-Bridging drugs could open kidney transplants to more donors
NCT ID NCT07706205
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This early-stage trial tests whether two immune-engaging drugs, blinatumomab and teclistamab, can safely lower blood-group antibodies in people awaiting a living-donor kidney transplant that is not blood-type compatible. The goal is to see if these drugs can prepare the body to accept a mismatched kidney. The study involves 20 adults with end-stage kidney disease and tracks antibody levels and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two bispecific T-cell engager drugs called blinatumomab and teclistamab
- What this could lead to
- If successful, this approach could expand the donor pool for kidney transplants by making blood-type mismatches less of a barrier.
- What could go wrong
- This is a very early, small trial (20 people) focused on safety and antibody reduction, not long-term transplant success. The drugs can cause serious side effects like cytokine release syndrome and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age ≥18 years old and ≤65 years old, regardless of gender 2. End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months 3. Plan to receive ABO-incompatible living donor kidney transplantation (ABOi-LDKT), and the matching has been approved by the organ transplantation ethics committee and technical committee of the hospital 4. Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method) 5. able to understand study procedures, provide written informed consent, and be willing and able to comply with the study visit schedule and laboratory examination requirements Exclusion Criteria: 1. patients allergic to the components of rituximab, teritumumab and berintuomab; 2. Hematologic diseases or myelosuppression (ANC \< 1.0×10⁹/L, PLT \< 75×10⁹/L); 3. multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time; 4. acute active infection (including HBV, HCV, HIV, uncontrolled bacterial/fungal infection); 5. Severe cardiac dysfunction (NYHA class III-IV) 6. known or suspected hereditary complement deficiency 7. abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) \> 3 times the upper limit of normal (ULN); Or alkaline phosphatase (ALP) or total bilirubin values greater than 1.5 times the upper limit of normal (ULN). 8. Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc. 9. complicated with other uncontrolled malignant tumors; 10. women who are pregnant, breastfeeding or planning to become pregnant; 11. patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases; 12. Patients who were not eligible for the study for other reasons according to the investigator's judgment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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