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Antibody Mediated Rejection After Kidney TransplantationPhase 4NCT07689578

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

A Phase 4 study testing BiTE (BCMA x CD3 Bispecific Antibody) in people with Antibody Mediated Rejection After Kidney Transplantation, run by Turun Song at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BiTE (BCMA x CD3 Bispecific Antibody)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
30 Jul 2026to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Functioning living or deceased donor allograft after ≥180 days post-transplantation.
  • eGFR ≥20 ml/min/1.73 m2 (CKD-EPI formula).
  • HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
  • Biopsy-confirmed chronic active antibody-mediated rejection (cAMR) according to the Banff 2019 criteria.
  • Voluntarily signed informed consent, with willingness and ability to adhere to regular follow-up and complete collection of all study-related information.

Who cannot join

  • Patients actively participating in another clinical trial.
  • Age <18 years.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Multi-organ recipients, e.g., patients with concurrent or prior bone marrow transplantation or other organ transplantation.
  • 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.
  • Previous treatment with any BCMA-targeted agent, including monoclonal antibodies (e.g., ADCs, bispecifics) or CAR-T cell therapy.
Show all 22Show fewer
  • Previous treatment with other immunomodulatory monoclonal/polyclonal antibodies (e.g. CD20 Ab rituximab, IL-6/IL-6R Ab) ≤3 months before study treatment.
  • Total bilirubin >2×the upper limit of normal [ULN], alanine transaminase and aspartate aminotransferase >2.5×ULN
  • Haemoglobin <8 g/dL
  • Thrombocytopenia: Platelets <100 G/L
  • Leukopenia: Leukocytes <3 G/L
  • Neutropenia: Neutrophils < 1.5 G/L
  • Hypogammaglobulinemia: Serum IgG <400 mg/dL
  • Active viral, bacterial, or fungal infection precluding intensified immunosuppression.
  • Active malignant disease precluding intensified immunosuppressive therapy.
  • Latent or active tuberculosis.
  • Administration of a live vaccine within 6 weeks of screening.
  • Central nervous system (CNS) disorders, including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or CNS vasculitis, visual disturbances, cranial neuropathy requiring intervention, etc.
  • History of alcohol or illicit substance abuse
  • Serious medical or psychiatric illness likely to interfere with participation in the study.
  • 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.
  • .

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunfei Xiao, Ph.D contact

+86 28 85422925

xiaoyunfeix@163.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

Other trials in China

About this study

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).
Being tested
BiTE (BCMA x CD3 Bispecific Antibody)
Keywords
Kidney Transplant Recipients with Chronic Active Antibody-Mediated Rejection, bispecific antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiTE (BCMA x CD3 Bispecific Antibody)Drug

    Subcutaneous administration of BCMA x CD3 Bispecific Antibody

Study groups in NCT07689578
Study groupRoleWhat they receive
Bispecific T cell engager treatment groupExperimentalBiTE (BCMA x CD3 Bispecific Antibody)
Receives: Drug: BiTE (BCMA x CD3 Bispecific Antibody)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events

    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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (11)

  1. Leukocyte subsets in peripheral blood

    Flow cytometric analysis of T, B, and NK (TBNK) cell percentages and absolute counts in peripheral blood.

    Measured: Through study completion, an average of 1 year

  2. Serum immunoglobulin levels

    Ig (sub)classes (ELISA, Nephelometry)

    Measured: Through study completion, an average of 1 year

  3. Serum renal function

    Measured using an automated analyzer

    Measured: Through study completion, an average of 1 year

  4. HLA antibody detection

    HLA antibody profiling, with quantification of donor-specific antibody (DSA) levels. Luminex-based multiplex flow cytometric immunoassay

    Measured: Through study completion, an average of 1 year

  5. Plasma donor-derived cell-free DNA

    Detection was performed using fragment analysis combined with digital PCR

    Measured: Through study completion, an average of 1 year

  6. Pathological analysis of renal allograft biopsy

    Percutaneous biopsy of the renal allograft was obtained, and histopathological analysis was carried out in accordance with the Banff classification system.

    Measured: At baseline and every 6 months after treatment completion until study completion.

  7. Ultrasound of the renal allograft

    Ultrasound examination was performed to evaluate allograft perfusion and to document overall graft morphology.

    Measured: Through study completion, an average of 1 year

  8. Proteinuria: 24 hour urine protein

    24-hour urine protein quantifies total protein excretion collected over a 24-hour period.

    Measured: Through study completion, an average of 1 year

  9. Proteinuria: Urine protein to creatinine ratio

    Urinary protein excretion in spot urine

    Measured: Through study completion, an average of 1 year

  10. Graft loss

    Graft loss as determined by a return to dialysis or death.

    Measured: Through study completion, an average of 1 year

  11. Death

    patient survival as assessed by patients vital status.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start30 Jul 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07689578
Sponsor's protocol ID
WestChina-BITE-cAMR
Status last verified
Aug 2026
First submitted
24 Jun 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.

    PubMed 32463180

  • Moreau P, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Nooka AK, Martin T, Rosinol L, Chari A, Karlin L, Benboubker L, Mateos MV, Bahlis N, Popat R, Besemer B, Martinez-Lopez J, Sidana S, Delforge M, Pei L, Trancucci D, Verona R, Girgis S, Lin SXW, Olyslager Y, Jaffe M, Uhlar C, Stephenson T, Van Rampelbergh R, Banerjee A, Goldberg JD, Kobos R, Krishnan A, Usmani SZ. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022 Aug 11;387(6):495-505. doi: 10.1056/NEJMoa2203478. Epub 2022 Jun 5.

    PubMed 35661166

  • Leon J, Aubert O, Devriese M, Alameda F, Charbonnier S, Fourgeaud J, Blein T, Nguyen TN, Troger A, Chhun S, Roelens M, Usureau C, Gons C, Roger C, Burger C, Le Stang MB, Cotteret C, Timsit MO, Fillatreau S, Rabant M, Taupin JL, Talbot A, Suarez F, Anglicheau D, Zuber J. B-cell maturation antigen-Targeted T-cell Engager Therapy Combined with B-cell Depletion for Treatment of Refractory HLA Sensitization. Kidney Int. 2026 Jun;109(6):1148-1154. doi: 10.1016/j.kint.2026.01.020. Epub 2026 Feb 13.

    PubMed 41692345

  • Gregg-Garcia R, Abonour R, Suvannasankha A. Bispecific T-cell engagers for relapsed/refractory multiple myeloma after solid organ transplantation: A case series. J Investig Med. 2026 Apr;74(3):289-293. doi: 10.1177/10815589251364807. Epub 2025 Jul 28.

    PubMed 40722049

  • Forgeard N, Elessa D, Carpinteiro A, Belhadj K, Minnema M, Roussel M, Huart A, Javaugue V, Pascal L, Royer B, Talbot A, Gounot R, Hegenbart U, Schonland S, Karlin L, Harel S, Kastritis E, Bridoux F, Jaccard A, Arnulf B. Teclistamab in relapsed or refractory AL amyloidosis: a multinational retrospective case series. Blood. 2024 Feb 22;143(8):734-737. doi: 10.1182/blood.2023022937. No abstract available.

    PubMed 38096365

  • Schreiber S, Al-Dubai M, Vielhaber S, Lefterova L, Dietrich S, Ruck T, Meuth S, Walther D, Mougiakakos D. Effective use of BCMA-targeting bispecific T cell-engaging antibody in treatment-refractory LRP4+ myasthenia gravis. Mol Ther. 2025 Sep 3;33(9):4130-4134. doi: 10.1016/j.ymthe.2025.06.029. Epub 2025 Jun 17.

    PubMed 40534130

  • Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.

    PubMed 34388396

  • Baines AC, Kanapuru B, Zhao J, Price LSL, Zheng N, Konicki R, Manning ML, Gehrke BJ, Theoret MR, Gormley NJ. FDA Approval Summary: Teclistamab-A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2024 Dec 16;30(24):5515-5520. doi: 10.1158/1078-0432.CCR-24-1872.

    PubMed 39412823

  • de Nattes T, Camus V, Francois A, Dallet G, Ferrand C, Guerrot D, Lemoine M, Morin F, Thieblemont C, Veresezan EL, Candon S, Latouche JB, Bertrand D. Kidney Transplant T Cell-Mediated Rejection Occurring After Anti-CD19 CAR T-Cell Therapy for Refractory Aggressive Burkitt-like Lymphoma With 11q Aberration: A Case Report. Am J Kidney Dis. 2022 May;79(5):760-764. doi: 10.1053/j.ajkd.2021.07.012. Epub 2021 Aug 27.

    PubMed 34461166

  • Portuguese AJ, Gauthier J, Tykodi SS, Hall ET, Hirayama AV, Yeung CCS, Blosser CD. CD19 CAR-T therapy in solid organ transplant recipients: case report and systematic review. Bone Marrow Transplant. 2023 Apr;58(4):353-359. doi: 10.1038/s41409-022-01907-z. Epub 2022 Dec 27.

    PubMed 36575360

  • Guzzo I, Becilli M, Cappoli A, Merli P, Labbadia R, Del Bufalo F, Tomas NM, Colucci M, Huber TB, Algeri M, Andreani M, Emma F, Locatelli F. Anti-CD19 chimeric antigen receptor T-cell therapy in a highly sensitized patient with focal and segmental glomerulosclerosis. Pediatr Nephrol. 2025 Nov;40(11):3513-3519. doi: 10.1007/s00467-025-06884-1. Epub 2025 Jul 16.

    PubMed 40668377

  • Wang F, He K, Wang J, Zhao MH, Li Y, Zhang L, Saran R, Bragg-Gresham JL. Prevalence and Risk Factors for CKD: A Comparison Between the Adult Populations in China and the United States. Kidney Int Rep. 2018 Jun 2;3(5):1135-1143. doi: 10.1016/j.ekir.2018.05.011. eCollection 2018 Sep.

    PubMed 30197980

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BiTE (BCMA x CD3 Bispecific Antibody) in people with Antibody Mediated Rejection After Kidney Transplantation, run by Turun Song at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yunfei Xiao, Ph.D (+86 28 85422925, xiaoyunfeix@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07689578, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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