Immune-Bridging drugs could open kidney transplants to more donors

NCT ID NCT07706205

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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: 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

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  1. The official record

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