A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
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: Chimeric Antigen Receptor T Cells (CAR-T).
- Кому может быть актуально
- Состояния в реестре: B-cell Acute Lymphoblastic Leukemia. Базовые параметры: 18 лет — 75 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
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of Universal CAR-T Cell in Patients With CD19 and/or CD20 Positive Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.
Обзор
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.
Подробное описание
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.
Вмешательства
- Препарат Chimeric Antigen Receptor T Cells (CAR-T)
chimeric antigen receptor T cells
Первичные конечные точки
- MTD and/or dose range [Срок оценки: Up to 28 days after CAR-T cells infusion]
- Adverse Events (AE) after CT119X infusion [Срок оценки: 12 months after CT119X infusion]
Вторичные конечные точки (7)
- Overall response rate （ORR） [Срок оценки: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion]
- Complete response rate (CRR) [Срок оценки: 12 months after CT119X infusion]
- Duration of remission(DOR) [Срок оценки: 12 months after CT119X infusion]
- Time to response (TTR) [Срок оценки: 12 months after CT119X infusion]
- Time to complete response (TTCR) [Срок оценки: 12 months after CT119X infusion]
- Progression-free survival (PFS) [Срок оценки: 12 months after CT119X infusion]
- Overall survival (OS) [Срок оценки: 12 months after CT119X infusion]
Критерии участия
Критерии включения
- Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements
- 18-75 years old;
- Histologically or cytologically confirmed B-ALL;
- Previously received at least 2 lines of systemic therapy;
- Expected survival > 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) score 0-2;
- Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.
Критерии исключения
- Pregnant or lactating women;
- Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);
- Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
- Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;
- Patients with isolated extramedullary lesions;
- Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
- Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
- Patients with heart disease in the 6 months prior to screening;
- Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
- Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in 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
- Shanghai Tongji Hospital — Шанхай
Идентификаторы
NCT: NCT07043218 · CT119X-CG11004