NCT07689578 Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant Recipients With Chronic Active Antibody-Mediated Rejection
| NCT ID | NCT07689578 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Turun Song |
| Condition | Antibody Mediated Rejection After Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2026-07-30 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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).
Eligibility Criteria
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. .
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07689578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Antibody Mediated Rejection After Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07689578 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07689578 currently recruiting?
Yes, NCT07689578 is actively recruiting participants. Contact the research team at xiaoyunfeix@163.com for enrollment information.
Where is the NCT07689578 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07689578 clinical trial?
NCT07689578 is sponsored by Turun Song. The trial plans to enroll 50 participants.
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