New antibody therapy aims to stop chronic kidney transplant rejection

NCT ID NCT07689578

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This trial tests a bispecific T-cell engager (BiTE) antibody in kidney transplant recipients who have chronic active antibody-mediated rejection (cAMR). The BiTE targets BCMA and CD3 to deplete harmful B cells and plasma cells that produce donor-specific antibodies. Researchers will assess safety and whether the treatment can reduce antibody levels, improve kidney biopsy findings, and stabilize kidney function. The study enrolls 50 adults with biopsy-confirmed cAMR and stable kidney function.

What this could mean

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

Active substance
BCMA x CD3 Bispecific Antibody (BiTE)
What this could lead to
If successful, this could offer a new treatment option for kidney transplant patients with chronic rejection, potentially preserving kidney function and reducing the need for more aggressive therapies.
What could go wrong
This is a small, single-arm Phase 4 trial with no control group, so results may be preliminary. The BiTE therapy carries risks of immune-related side effects and infections, and its long-term safety in transplant recipients is unknown.

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

Phase 4

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

Participants

About 50 people

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

Started

Jul 2026

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 years and older

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. 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 antibody-mediated rejection (cAMR) according to the Banff 2019 criteria. 6. Voluntarily signed informed consent, with willingness and ability to adhere to regular follow-up and complete collection of all study-related information. Exclusion Criteria: 1. Patients actively participating in another clinical trial. 2. Age \<18 years. 3. Pregnancy, lactation, or planned pregnancy during the study period. 4. Multi-organ recipients, e.g., patients with concurrent or prior bone marrow transplantation or other organ transplantation. 5. Kidney transplantation biopsy combined with one of the following results: A. T-cell-mediated rejection classified Banff grade ≥I. B. De novo or recurrent severe thrombotic microangiopathy. C. Polyoma virus nephropathy, De novo or recurrent glomerulonephritis. 6. Previous treatment with any BCMA-targeted agent, including monoclonal antibodies (e.g., ADCs, bispecifics) or CAR-T cell therapy. 7. Previous treatment with other immunomodulatory monoclonal/polyclonal antibodies (e.g. CD20 Ab rituximab, IL-6/IL-6R Ab) ≤3 months before study treatment. 8. Total bilirubin \>2×the upper limit of normal \[ULN\], alanine transaminase and aspartate aminotransferase \>2.5×ULN 9. Haemoglobin \<8 g/dL 10. Thrombocytopenia: Platelets \<100 G/L 11. Leukopenia: Leukocytes \<3 G/L 12. Neutropenia: Neutrophils \< 1.5 G/L 13. Hypogammaglobulinemia: Serum IgG \<400 mg/dL 14. Active viral, bacterial, or fungal infection precluding intensified immunosuppression. 15. Active malignant disease precluding intensified immunosuppressive therapy. 16. Latent or active tuberculosis. 17. Administration of a live vaccine within 6 weeks of screening. 18. Central nervous system (CNS) disorders, including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or CNS vasculitis, visual disturbances, cranial neuropathy requiring intervention, etc. 19. History of alcohol or illicit substance abuse 20. Serious medical or psychiatric illness likely to interfere with participation in the study. 21. Presence of any other clinically significant medical history or current disease that, in the judgment of the investigator, would compromise subject safety, impede completion of the study protocol, or compromise the assessment of safety and efficacy. .

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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 places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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