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Идёт набор NCT07300683

Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma

Фаза I С лечением T Cell Acute Lymphoblastic Leukemia T Cell Lymphoblastic Lymphoma

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: CARCCR9 T cells.
Кому может быть актуально
Состояния в реестре: T Cell Acute Lymphoblastic Leukemia, T Cell Lymphoblastic Lymphoma. Базовые параметры: Без ограничений · 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
Великобритания
Следующий шаг
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Официальное название

Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma

Обзор

The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma. Participants will: * have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory. * be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells. * be given the CAR T cells into their vein. * stay in the hospital for a minimum of 2 weeks to be closely monitored * following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years) * during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.

Вмешательства

  • Биопрепарат CARCCR9 T cells
    Anti-CCR9 CAR T cells

Первичные конечные точки

  • Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated. [Срок оценки: 2 years]
  • Incidence of treatment-related adverse events (safety and tolerability) [Срок оценки: From CAR T cells infusion until 28 days post infusion]
Вторичные конечные точки (7)
  • Persistence of CARCCR9 T cells [Срок оценки: From CAR T cells infusion until 2 years post infusion]
  • Expansion of CARCCR9 T cells [Срок оценки: From CAR T cells infusion until 2 years post infusion]
  • Potential efficacy of CARCCR9 T cells [Срок оценки: At 1 and 2 years post CAR T cells infusion]
  • Potential efficacy of CARCCR9 T cells [Срок оценки: At 1 and 2 years post CAR T cells infusion]
  • Time to disease progression [Срок оценки: From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.]
  • Event free survival [Срок оценки: From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.]
  • Overall survival [Срок оценки: From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.]

Критерии участия

Критерии включения

  • Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
  • CCR9-positive disease as assessed by flow cytometry
  • T-LBL patients only: Patients must have measurable disease
  • Agreement to have a pregnancy test, use adequate contraception (if applicable)
  • Written informed consent

Критерии исключения

  • ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
  • Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
  • Active CNS involvement of disease
  • Active hepatitis B, C or HIV infection
  • Oxygen saturation ≤90% on air
  • Bilirubin >3 x upper limit of normal
  • GFR <30 ml/min
  • Cardiac dysfunction
  • Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
  • Known allergy to any component of the ATIMP
  • Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
  • Women who are pregnant or breastfeeding
  • Life expectancy <3 months
  • Fulminant or rapidly progressive disease

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

Великобритания · 1 центр
  • University College London Hospitals — London

Идентификаторы

NCT: NCT07300683 · UCL/150854 · 2022-003497-23 · ISRCTN15341827

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗