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Набор скоро начнётся NCT07706205

Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation

Ранняя фаза I С лечением ABO Blood Type Incompatible Kidney Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Blinatumomab Treatment, Teclistamab treat.
Кому может быть актуально
Состояния в реестре: ABO Blood Type Incompatible Kidney Transplantation. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Препарат Blinatumomab Treatment
    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
  • Препарат Teclistamab treat
    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

Первичные конечные точки

  • Blood group antibody titer [Срок оценки: Within 2 months after the end of treatment]
Вторичные конечные точки (1)
  • Safety of Treatment [Срок оценки: From treatment to the end of transplantation at 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07706205 · WestChina-BITE-ABOi

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗