A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin 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: LUCAR-20SP cells.
- Кому может быть актуально
- Состояния в реестре: Relapsed B-cell Non-Hodgkin Lymphoma, Refractory B-cell Non-Hodgkin Lymphoma. Базовые параметры: от 18 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 →
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Официальное название
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Обзор
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Подробное описание
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.
Вмешательства
- Биопрепарат LUCAR-20SP cells
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Первичные конечные точки
- Dose-limiting toxicity (DLT) rate [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs) [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Recommended Phase 2 Dose (RP2D) regimen finding [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Pharmacokinetics in peripheral blood [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Pharmacokinetics in bone marrow [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Вторичные конечные точки (6)
- Objective Response Rate (ORR) after administration [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Time to Response (TTR) after administration [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Duration of Remission (DoR) after administration [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Progression-free Survival (PFS) after administration [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]]
- Overall Survival (OS) after administration [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]]
- Incidence of anti-LUCAR-20SP antibody [Срок оценки: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Критерии участия
Критерии включения
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
- At least one measurable tumor lesion according to the Lugano 2014.
- Expected survival ≥3 months;
- Clinical laboratory values in the screening period meet criteria.
- Effective contraception.
Критерии исключения
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
- Previously received allogeneic hematopoietic stem cell transplantation;
- Previously received gene therapy;
- Donor specific antibody (DSA) positive subjects will be excluded;
- Severe underlying diseases;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this 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 · 3 центра
- Beijing GoBroad Boren Hospital — Пекин
- Peking University Cancer Hospital & Institute — Пекин
- Henan Cancer Hospital — Чжэнчжоу
Идентификаторы
NCT: NCT06313957 · LB2302-0001