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Идёт набор NCT05717699

Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma

Фаза I С лечением Oncolytic Virus Diffuse Intrinsic Pontine Glioma Adverse Drug Event

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: Ad-TD-nsIL12.
Кому может быть актуально
Состояния в реестре: Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event. Базовые параметры: 1 год — 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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Обзор

This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).

Вмешательства

  • Биопрепарат Ad-TD-nsIL12
    After stereotactic biopsy, the Ommaya reservoir will be inserted through the biopsy channel and two injections of Ad-TD-nsIL12 will be delivered after surgery by Ommaya reservoir (with an interval of 3days). The interval between following injections in the subsequent treatment period will be 3 weeks ±4 days. The assigned dose for each patient will be 3x10\^9vp, 1x10\^10vp or 3x10\^10 vp suspended in 1 ml NS according to cohort design.

Первичные конечные точки

  • Safety of Ad-TD-nsIL12 intratumoral injection in progressive pediatric DIPG patients. [Срок оценки: 3 months after virus injection]
Вторичные конечные точки (4)
  • Tumor response [Срок оценки: 3 months after virus injection]
  • Over-all survival [Срок оценки: 12 months after virus injection]
  • QoL [Срок оценки: 2 years after virus injection]
  • Sample Collection [Срок оценки: 3 months after virus injection]

Критерии участия

Критерии включения

  • Informed consent of the parents or patient.
  • After surgical resection, biopsy, chemotherapy, or radiation therapy, tumor progression must be confirmed by MRI scan.
  • Biopsy is performed prior to injection of Ad-TD-nsIL12 to confirm DIPG (frozen section-based).
  • Pre-enrollment patients LPS (patients aged ≥1 and <16 years) and KPS (patients aged ≥16 years) ≥ 50.
  • Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
  • Age 1-18 years.
  • A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
  • Lesion considered by the investigator to be accessible for stereotactic biopsy.

Критерии исключения

  • Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. Patients must be afebrile (<38℃) at the time of viral therapy.
  • Other investigational medications within 30 days prior to viral treatment.
  • Participants with immunodeficiency, autoimmune disease, or active hepatitis.
  • Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
  • Tumor with multiple location.
  • Pregnant or breast-feeding females.
  • Severe bone marrow hypoplasia.
  • Transaminases (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 3 times the upper limit of normal.
  • Neutrophils < 1x10\^9/L.
  • Platelets ≤ 100x10\^9/L.
  • Hemoglobin < 9g/dl.
  • Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways.
  • Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration.
  • Blood transfusions or drugs (such as G-CSF) within 28 days before viral treatment to treat pancytopenia or other hematological disorders.

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
  • Sanbo Brain Hospital, Capital Medical University — Пекин

Публикации

  • Zhang Z, Zhang C, Miao J, Wang Z, Wang Z, Cheng Z, Wang P, Dunmall LSC, Lemoine NR, Wang Y. A Tumor-Targeted Replicating Oncolytic Adenovirus Ad-TD-nsIL12 as a Promising Therapeutic Agent for Human Esophageal Squamous Cell Carcinoma. Cells. 2020 Nov 10;9(11):2438. doi: 10.3390/cells9112438. PMID 33182528
  • Bortolanza S, Bunuales M, Otano I, Gonzalez-Aseguinolaza G, Ortiz-de-Solorzano C, Perez D, Prieto J, Hernandez-Alcoceba R. Treatment of pancreatic cancer with an oncolytic adenovirus expressing interleukin-12 in Syrian hamsters. Mol Ther. 2009 Apr;17(4):614-22. doi: 10.1038/mt.2009.9. Epub 2009 Feb 17. PMID 19223865
  • Wang P, Li X, Wang J, Gao D, Li Y, Li H, Chu Y, Zhang Z, Liu H, Jiang G, Cheng Z, Wang S, Dong J, Feng B, Chard LS, Lemoine NR, Wang Y. Re-designing Interleukin-12 to enhance its safety and potential as an anti-tumor immunotherapeutic agent. Nat Commun. 2017 Nov 9;8(1):1395. doi: 10.1038/s41467-017-01385-8. PMID 29123084

Идентификаторы

NCT: NCT05717699 · Ad-TD-nsIL12 for Pro-DIPG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗