Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant Recipients With Chronic Active Antibody-Mediated Rejection

August 2, 2026 updated by: Turun Song

This clinical trial aims to determine whether a bispecific T-cell engager (BiTE) targeting BCMA×CD3 effectively treats chronic active antibody-mediated rejection (cAMR) in kidney transplant recipients. The study also investigates the safety of BiTE in this patient population.

The main questions it aims to answer are:

  1. Is BiTE safe and tolerable in kidney transplant recipients with cAMR?
  2. Can BiTE improve cAMR? (i.e., can it reduce donor-specific antibody levels, ameliorate histological injury on transplant biopsy, and stabilize or improve kidney function by depleting pathogenic B cells and plasma cells?) Researchers will evaluate the effects of BiTE by comparing clinical outcomes before and after treatment in all participants, as this is a single-arm study (all participants receive the same treatment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

    .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bispecific T cell engager treatment group
BiTE (BCMA x CD3 Bispecific Antibody)
Drug: BiTE (BCMA x CD3 Bispecific Antibody)
Subcutaneous administration of BCMA x CD3 Bispecific Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: Through study completion, an average of 1 year
Throughout the study, safety monitoring will comprise adverse event (AE) surveillance, routine laboratory assessments, and viral polymerase chain reaction (PCR) testing. All AEs and serious adverse events (SAEs) will be classified according to the Medical Dictionary for Regulatory Activities (MedDRA). Documentation of each AE will include both an assessment of its relationship to the investigational product (categorized as either unrelated or related) and a severity grade based on predefined criteria.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukocyte subsets in peripheral blood
Time Frame: Through study completion, an average of 1 year
Flow cytometric analysis of T, B, and NK (TBNK) cell percentages and absolute counts in peripheral blood.
Through study completion, an average of 1 year
Serum immunoglobulin levels
Time Frame: Through study completion, an average of 1 year
Ig (sub)classes (ELISA, Nephelometry)
Through study completion, an average of 1 year
Serum renal function
Time Frame: Through study completion, an average of 1 year
Measured using an automated analyzer
Through study completion, an average of 1 year
HLA antibody detection
Time Frame: Through study completion, an average of 1 year
HLA antibody profiling, with quantification of donor-specific antibody (DSA) levels. Luminex-based multiplex flow cytometric immunoassay
Through study completion, an average of 1 year
Plasma donor-derived cell-free DNA
Time Frame: Through study completion, an average of 1 year
Detection was performed using fragment analysis combined with digital PCR
Through study completion, an average of 1 year
Pathological analysis of renal allograft biopsy
Time Frame: At baseline and every 6 months after treatment completion until study completion.
Percutaneous biopsy of the renal allograft was obtained, and histopathological analysis was carried out in accordance with the Banff classification system.
At baseline and every 6 months after treatment completion until study completion.
Ultrasound of the renal allograft
Time Frame: Through study completion, an average of 1 year
Ultrasound examination was performed to evaluate allograft perfusion and to document overall graft morphology.
Through study completion, an average of 1 year
Proteinuria: 24 hour urine protein
Time Frame: Through study completion, an average of 1 year
24-hour urine protein quantifies total protein excretion collected over a 24-hour period.
Through study completion, an average of 1 year
Proteinuria: Urine protein to creatinine ratio
Time Frame: Through study completion, an average of 1 year
Urinary protein excretion in spot urine
Through study completion, an average of 1 year
Graft loss
Time Frame: Through study completion, an average of 1 year
Graft loss as determined by a return to dialysis or death.
Through study completion, an average of 1 year
Death
Time Frame: Through study completion, an average of 1 year
patient survival as assessed by patients vital status.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turun Song

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChina-BITE-cAMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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