Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation
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.
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Teclistamab Group
|
Cycle 1 (Day 1-day 9) Day1 0.06mg/kg, Day2 0.3mg/kg; Cycle 2 was performed after a 7-day interval.
Cycle 2 (Day 10-Day 13) Day10 1.5mg/kg
|
|
实验性的:Blinatumomab Group
|
Blinatumomab: Cycle 1 (Day 0-Day 6) : 9ug/Day for 5 consecutive days, total dose 38.5ug; Cycle 2 was performed after a 9-day hospital interval; Cycle 2 (Day7-Day13) was 9ug/day on the first day for 5 consecutive days, and the total treatment dose was 38.5ug
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood group antibody titer
大体时间: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
|
Within 2 months after the end of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety of Treatment
大体时间:From treatment to the end of transplantation at 1 year
|
The incidence of drug-related adverse reactions (CRS, ICANS, infection, bone marrow suppression, hypogammaglobulinemia, infusion/injection reactions, catheter-related complications, etc.) during treatment and follow-up period
|
From treatment to the end of transplantation at 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- WestChina-BITE-ABOi
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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