Меню
Идёт набор NCT06773091

A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

Фаза I С лечением Advanced Solid Tumors

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: NK042, Fludarabine (FLU), Cyclophosphamide (CTX).
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumors. Базовые параметры: 18 лет — 70 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

An Open-Label, Single-Arm, Multicenter Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of NK042 Cell Injection (Universal NKR+NK) in Advanced Solid Tumors

Обзор

This is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of NK042 cell injection in patients with advanced solid tumors.

Подробное описание

This study is divided into two phases: Phase Ia and Phase Ib.

Dose-Escalation and Expansion:

* Phase Ia: This dose-escalation phase involves both single-dose and multiple-dose administrations of NK042 in patients with advanced solid tumors. * Phase Ib: This multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

Вмешательства

  • Биопрепарат NK042
    NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells.
  • Препарат Fludarabine (FLU)
    Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.
  • Препарат Cyclophosphamide (CTX)
    Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.

Первичные конечные точки

  • Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 1 year after first dose of NK042.]
  • Dose Limiting Toxicities (DLTs) [Срок оценки: Up to 28-day after first dose of NK042.]
  • Objective Response Rate (ORR) [Срок оценки: Up to 1 year after first dose of NK042.]
Вторичные конечные точки (8)
  • Peak plasma concentration (Cmax) [Срок оценки: Predose, 4, 24, 48, 72, Day 8, Day 15, Day 22, Day 29 post-dose and every 2 months during the treatment follow-up period.]
  • Time to reach maximum concentration (Tmax) [Срок оценки: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.]
  • Area under the plasma concentration versus time curve (AUC₀-ₜ) [Срок оценки: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.]
  • Half-life (T₁/₂) of NK042 [Срок оценки: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.]
  • Progression-Free Survival (PFS) [Срок оценки: Up to 1 year after first dose of NK042 .]
  • Overall Survival (OS) [Срок оценки: Up to 1 year after first dose of NK042 .]
  • Duration of Response (DOR) [Срок оценки: Up to 1 year after first dose of NK042 .]
  • Disease Control Rate (DCR) [Срок оценки: Up to 1 year after first dose of NK042 .]

Критерии участия

Критерии включения

  • Voluntary signing of a written informed consent form.
  • Age between 18 and 70 years.
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment.
  • At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Expected survival ≥12 weeks.
  • Must have adequate bone marrow, liver, and renal function.

Критерии исключения

  • Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
  • Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
  • Requirement for anticoagulation therapy.
  • Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
  • Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
  • Uncontrolled active infections.
  • Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
  • Previous receipt of other cellular therapies.
  • Planned concurrent participation in other anti-tumor treatments during the study.
  • Pregnant or breastfeeding women.

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
  • Peking University Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06773091 · NK042-I-ST-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗