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

NCT07689578 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: WestChina-BITE-cAMR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. The main questions it aims to answer are:

1. 1.Is BiTE safe and tolerable in kidney transplant recipients with cAMR?
2. 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).

Conditions

Antibody Mediated Rejection After Kidney Transplantation

Keywords

Kidney Transplant Recipients with Chronic Active Antibody-Mediated Rejection; bispecific antibody

Outcome Measures

Primary Outcomes (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.

  Through study completion, an average of 1 year

Secondary Outcomes (11)

• Leukocyte subsets in peripheral blood

  Through study completion, an average of 1 year

• Serum immunoglobulin levels

  Through study completion, an average of 1 year

• Serum renal function

  Through study completion, an average of 1 year

• HLA antibody detection

  Through study completion, an average of 1 year

• Plasma donor-derived cell-free DNA

  Through study completion, an average of 1 year

Study Arms (1)

Bispecific T cell engager treatment group

EXPERIMENTAL

BiTE (BCMA x CD3 Bispecific Antibody)

Drug: BiTE (BCMA x CD3 Bispecific Antibody)

Interventions

BiTE (BCMA x CD3 Bispecific Antibody) DRUG

Subcutaneous administration of BCMA x CD3 Bispecific Antibody

Bispecific T cell engager treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (12)

• 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.

  PMID: 32463180 RESULT

• 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.

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• 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.

  PMID: 41692345 RESULT

• 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.

  PMID: 40722049 RESULT

• 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.

  PMID: 38096365 RESULT

• 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.

  PMID: 40534130 RESULT

• 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.

  PMID: 34388396 RESULT

• 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.

  PMID: 39412823 RESULT

• 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.

  PMID: 34461166 RESULT

• 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.

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  PMID: 40668377 RESULT

• 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.

  PMID: 30197980 RESULT

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Yunfei Xiao, Ph.D

CONTACT

+86 18382311011; xiaoyunfeix@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share