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Идёт набор NCT07661537

A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma

Фаза I С лечением 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: SHR-3079 Injection.
Кому может быть актуально
Состояния в реестре: 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

An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma

Обзор

The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.

Вмешательства

  • Препарат SHR-3079 Injection
    SHR-3079 injection.

Первичные конечные точки

  • Dose-limiting Toxicity (DLT) [Срок оценки: 28 days after treatment initiation.]
  • Maximum tolerated dose (MTD) [Срок оценки: Approximately 1 year.]
  • Recommended Phase II Dose (RP2D) [Срок оценки: Approximately 1 year.]
Вторичные конечные точки (12)
  • Types, incidence and severity of Adverse events (AEs) [Срок оценки: Approximately 1 year.]
  • Serious adverse events (SAEs) [Срок оценки: Approximately 1 year.]
  • Peak concentration (Cmax) [Срок оценки: Approximately 1 year.]
  • Time to peak concentration (Tmax) [Срок оценки: Approximately 1 year.]
  • Area under the curve (AUC0-t, AUC0-inf) [Срок оценки: Approximately 1 year.]
  • Half-life (t1/2) [Срок оценки: Approximately 1 year.]
  • Apparent clearance (CL/F) [Срок оценки: Approximately 1 year.]
  • Apparent volume of distribution (Vz/F) [Срок оценки: Approximately 1 year.]
  • Objective Response Rate (ORR) [Срок оценки: Approximately 1 year.]
  • Best Overall Efficacy(BOR) [Срок оценки: Approximately 1 year.]
  • Time to Response (TTR) [Срок оценки: Approximately 1 year.]
  • Duration of Response (DoR) [Срок оценки: Approximately 1 year.]

Критерии участия

Критерии включения

  • Aged ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
  • Histologically confirmed B-NHL;
  • Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
  • Have measurable lesions;
  • Have adequate organ function;
  • Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;
  • Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.

Критерии исключения

  • Central nervous system (CNS) infiltration;
  • Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
  • Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
  • Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
  • Receipt of allogeneic hematopoietic stem cell transplantation;
  • Prior solid organ transplantation;
  • Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;
  • Presence of severe disorders involving major organ systems;
  • Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
  • Pregnant, lactating women, or women planning to become pregnant;
  • Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.

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 · 2 центра
  • Beijing Cancer Hospital — Пекин
  • Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07661537 · SHR-3079-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗