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Набор скоро начнётся NCT06567366

CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Фаза II С лечением Large B-cell 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: CAR T-cell therapy, Glofitamab, Obinutuzumab.
Кому может быть актуально
Состояния в реестре: Large B-cell 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 Single-Center, Prospective Study Evaluating the Efficacy and Safety of CAR T-cell Therapy in Combination With Glofitamab in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Обзор

The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.

Вмешательства

  • Биопрепарат CAR T-cell therapy
    Participants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).
  • Препарат Glofitamab
    Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant).
  • Препарат Obinutuzumab
    Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Первичные конечные точки

  • Complete Response (CR) Rate [Срок оценки: Up to 2 years]
Вторичные конечные точки (5)
  • Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
  • Duration of Response (DoR) [Срок оценки: Up to 2 years]
  • Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
  • Overall Survival (OS) [Срок оценки: Up to 2 years]
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

  • Signed Informed Consent Form
  • Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma (HGBL); and transformed follicular lymphoma
  • Patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal antibody therapy
  • Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed suitable for CAR-T and Glofitamab treatment by the investigator
  • Presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter > 4 cm; (3) TP53 mutation
  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy ≥12 weeks
  • Adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function

Критерии исключения

  • Hypersensitivity to any study drug or excipient
  • History of allogeneic stem cell transplantation
  • Patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B surface antigen or core antibody); patients who test positive for HCV RNA (HCV testing only for patients who test positive for HCV antibody)
  • Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc
  • History of HIV infection
  • Presence or concurrence of other malignancies within the past 2 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors
  • Previous anti-CD19 CAR-T therapy is not allowed
  • Pregnant or lactating women
  • Other uncontrollable medical condition that may interfere the participation of 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 Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT06567366 · Glofit-CART

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗