Идёт набор NCT05377307

Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy

— Наблюдательное Diffuse Large B Cell Lymphoma Large B-cell Lymphoma Primary Mediastinal Large B Cell Lymphoma Follicular Lymphoma Grade 3A

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: Pell's lentiviral-based gene-edited immune cell therapy.
Кому может быть актуально: Состояния в реестре: Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A. 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: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy

Обзор

According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.

Подробное описание

After completion or early withdraw from the other treatment protocol, patients should be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.

Вмешательства

Генная терапия Pell's lentiviral-based gene-edited immune cell therapy
No study drug or other planned treatment will be administered. Subjects who previously received Pell's lentiviral-based gene-edited immune cell therapy will be evaluated the safety and efficacy.

Первичные конечные точки

To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy [Срок оценки: 15 years]

Вторичные конечные точки (4)

Monitor for Replication Competent of Lentivirus (RCL) [Срок оценки: 15 years]
Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR) [Срок оценки: 15 years]
Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry) [Срок оценки: 5 years]
To assess the long-term efficacy of gene-edited immune cells [Срок оценки: 15 years]

Критерии участия

Критерии включения

Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.
The last lentiviral-based gene-edited immune cell infusion within 15 years.
Patient/patient's parent/legal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.