BiTE therapy for chronic active antibody-mediated rejection after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, single-arm trial evaluating safety and potential efficacy of a BCMA×CD3 BiTE in kidney transplant recipients with chronic active antibody-mediated rejection. Participants receive the BiTE and are followed to monitor safety, immune response, donor-specific antibody levels, biopsy findings, and kidney function. The study compares outcomes before and after treatment within the same participants. Enrollment requires adults with a functioning transplant for at least six months and biopsy-confirmed cAMR, among other criteria.

Why it matters

Who can join: the full rules

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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Where it's running

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

Study contacts

• Study coordinator: Yunfei Xiao, Ph.D
• Email: xiaoyunfeix@163.com
• Phone: +86 28 85422925

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.