NCT07689578招募中4 期
Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) in Kidney Transplant Recipients With Chronic Active Antibody-Mediated Rejection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Turun Song
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
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:
- Is BiTE safe and tolerable in kidney transplant recipients with cAMR?
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Bispecific T cell engager treatment group
Experimental
BiTE (BCMA x CD3 Bispecific Antibody)
干预措施: BiTE (BCMA x CD3 Bispecific Antibody) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 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.
次要结局
- 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)
- Pathological analysis of renal allograft biopsy(At baseline and every 6 months after treatment completion until study completion.)
- Ultrasound of the renal allograft(Through study completion, an average of 1 year)
- Proteinuria: 24 hour urine protein(Through study completion, an average of 1 year)
- Proteinuria: Urine protein to creatinine ratio(Through study completion, an average of 1 year)
- Graft loss(Through study completion, an average of 1 year)
- Death(Through study completion, an average of 1 year)
研究者
Turun Song
Associate Chief Physician
West China Hospital
研究点 (1)
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