New antibody therapy aims to stop chronic kidney transplant rejection
NCT ID NCT07689578
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2029
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 years and older
- 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. 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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.
Contacts and locations
Locations
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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