Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Blood group antibody titer
研究概览
简要总结
The goal of this clinical trial was to determine whether the Bites drugs (Blinatumomab and Teclistamab) can reduce blood group antibodies in recipients of living donor blood-incompatible kidney transplants for pretransplant conditioning. It will also understand the safety of Bites drugs in the transplant population. The main questions it aims to answer include:
Can Bites effectively reduce blood group antibodies? What are the safety concerns that participants may have when using Bites?
Participants will:
Be given Blinatumomab and Teclistamab at the standard dose prescribed by the manufacturer before surgery, and blood group antibodies were rechecked every two weeks to two months.
The adverse drug reactions and the times of rescue were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤65 years old, regardless of gender
- •End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months
- •Plan to receive ABO-incompatible living donor kidney transplantation (ABOi-LDKT), and the matching has been approved by the organ transplantation ethics committee and technical committee of the hospital
- •Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)
- •able to understand study procedures, provide written informed consent, and be willing and able to comply with the study visit schedule and laboratory examination requirements
排除标准
- •patients allergic to the components of rituximab, teritumumab and berintuomab;
- •Hematologic diseases or myelosuppression (ANC < 1.0×10⁹/L, PLT < 75×10⁹/L);
- •multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;
- •acute active infection (including HBV, HCV, HIV, uncontrolled bacterial/fungal infection);
- •Severe cardiac dysfunction (NYHA class III-IV)
- •known or suspected hereditary complement deficiency
- •abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) > 3 times the upper limit of normal (ULN); Or alkaline phosphatase (ALP) or total bilirubin values greater than 1.5 times the upper limit of normal (ULN).
- •Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.
- •complicated with other uncontrolled malignant tumors;
- •women who are pregnant, breastfeeding or planning to become pregnant;
- •patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;
- •Patients who were not eligible for the study for other reasons according to the investigator's judgment.
结局指标
主要结局
Blood group antibody titer
时间窗: Within 2 months after the end of treatment
The blood group antibody titer (IgG+IgM) was reduced to ≤1:8-16 within a specified time window (repeated twice within 2 months) after the end of the drug administration, and this standard status was maintained until the day of surgery
次要结局
- Safety of Treatment(From treatment to the end of transplantation at 1 year)
研究者
Turun Song
Associate Professor
West China Hospital