Меню
Идёт набор NCT06420063

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Фаза I / Фаза II С лечением AML Acute Myeloid Leukemia AML, Adult Recurrent AML, Adult

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: CD123/CD33 CART.
Кому может быть актуально
Состояния в реестре: AML, Acute Myeloid Leukemia, AML, Adult Recurrent, AML, Adult. Базовые параметры: 6 лет — 90 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukaemia

Обзор

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.

Подробное описание

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may have the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD33/CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

The purpose of this clinical trial is to assess the feasibility, safety, and efficacy of multiple CAR T-cell therapy which combines CAR T cells against AML Cells with CAR T cells targeting CD123 or CD33 in patients with relapsed and refractory AML. The study also aims to learn more about the function of CAR T cells and their persistence in AML patients.

Вмешательства

  • Биопрепарат CD123/CD33 CART
    The intervention in this clinical trial involves a novel approach using CD22/123-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's

Первичные конечные точки

  • Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD5/CD7 chimeric antigen receptor (CAR) T cells [Срок оценки: 28 days]
Вторичные конечные точки (1)
  • Rate of successful manufacture and expansion of the CD33/123 chimeric antigen receptor (CAR) T cells [Срок оценки: 10-14 days]

Критерии участия

Критерии включения

  • Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:
  • Age older than 6 months.
  • Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry.
  • Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
  • Hgb≥80g/L.
  • No cell separation contraindications.
  • Abilities to understand and the willingness to provide written informed consent.

Критерии исключения

  • Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
  • Active bacterial, fungal or viral infection not controlled by adequate treatment.
  • Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Pregnant or nursing women may not participate.
  • Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
  • Patients, in the opinion of investigators, may not be able to comply with the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • District One Hospital — Пекин

Идентификаторы

NCT: NCT06420063 · ESBI202495

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗