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Идёт набор NCT07556276

Study of CMTS1215 Injection in Patients With Solid Tumors

Фаза I / Фаза II С лечением Solid Tumor

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: CMTS1215 Oncolytic Bacteria.
Кому может быть актуально
Состояния в реестре: Solid Tumor. 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
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Официальное название

A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors

Обзор

This is a prospective, open-label, single-arm exploratory clinical trial to evaluate the safety and efficacy of CMTS1215 (Proteus mirabilis) oncolytic bacteria injection for the treatment of solid tumors. The study aims to enroll at least 8 patients with histologically confirmed solid tumors who have failed or are unable to complete conventional first-line, second-line, or third-line anti-tumor therapies.

Подробное описание

Oncolytic bacteria are a class of bacteria that can specifically reproduce within tumors and cause tumor cell death while activating the host immune system. CMTS1215 is a Proteus mirabilis strain developed by the research team with demonstrated oncolytic effects in preclinical studies. The bacteria show excellent tumor tropism and have been shown to be safe and effective in mouse and canine models.

This study will evaluate the tumor response rate at 1 week and 4 weeks post-treatment according to RECIST 1.1 criteria, as well as assess the safety profile of the treatment. Patients will receive intratumoral injection of CMTS1215 under direct visualization or endoscopic guidance for up to 6-8 treatment cycles.

Вмешательства

  • Биопрепарат CMTS1215 Oncolytic Bacteria
    CMTS1215 is a bacterial therapeutic preparation designated with the code CMTS1215. The mechanism of action may involve bacterial membrane proteins that facilitate tumor-targeting properties. CMTS1215 is administered via intratumoral injection (under direct visualization or endoscopic guidance) or intravenous injection, with dosage calculated based on tumor size.

Первичные конечные точки

  • Objective Response Rate (ORR) as Assessed by RECIST v1.1 [Срок оценки: 1 week, 4 weeks,]
  • Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: From informed consent through 6 months after the last dose of CMTS1215, or until resolution of any ongoing treatment-related adverse events, whichever is longer]
Вторичные конечные точки (3)
  • Progression-Free Survival (PFS) as Assessed by RECIST v1.1 [Срок оценки: From first dose through 12 months, or until disease progression/death]
  • Overall Survival (OS) Defined as Time from First Dose to Death from Any Cause [Срок оценки: From first dose through 12 months]
  • CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR [Срок оценки: Baseline and up to 3 months]

Критерии участия

Критерии включения

  • Adults aged 18 years or older, any gender
  • Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1
  • Failed or unable to complete conventional first-line, second-line, or third-line anti-tumor therapies, with multidisciplinary team consensus that no other suitable treatment options are available
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Expected survival time > 3 months 6 Voluntary participation with signed informed consent

Критерии исключения

  • Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia)
  • Active severe clinical infection (> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection
  • Coagulation abnormalities with bleeding tendency (INR outside normal range without anticoagulants within 14 days prior to enrollment); patients on anticoagulants or vitamin K antagonists (warfarin, heparin, or similar)
  • History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation
  • Lactating female patients
  • Currently participating in other clinical studies
  • Women of childbearing potential planning pregnancy during the study period
  • Patients with allergies to common antibiotics
  • Patients lacking or with restricted legal capacity
  • Other patients deemed unsuitable for enrollment by the investigator

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
  • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affi — Нанкин

Идентификаторы

NCT: NCT07556276 · CMTS1215-ST

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗