NCT05717699招募中1 期
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
Capital Medical University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年1月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety of Ad-TD-nsIL12 intratumoral injection in progressive pediatric DIPG patients.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Safety of Ad-TD-nsIL12 intratumoral injection in progressive pediatric DIPG patients.
时间窗: 3 months after virus injection
The trial will look for possible hematologic and neurologic toxicity of Ad-TD-nsIL12 by NCI-CTCAE v5.0 to determine maximum tolerated dose of this oncolytic adenovirus.
次要结局
- Tumor response(3 months after virus injection)
- QoL(2 years after virus injection)
- Sample Collection(3 months after virus injection)
- Over-all survival(12 months after virus injection)
研究者
Hongwei Zhang
Professor
Capital Medical University
研究点 (1)
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