NCT07243340招募中1 期
A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor
ImmVira Pharma Co. Ltd2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年4月3日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Phase I: Incidence of adverse event
研究概览
简要总结
This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Confirmed recurrent malignant high-grade (WHO grade 3-4) glioma who have received standard therapy and no available treatment.
- •Measurable lesions exist in accordance with RANO criteria.
- •Sufficient space for ≥1 mL drug infused into tumor cavity post resection.
- •Ommaya reservoir has been placed in the operation area, and drug administration conditions are available.
- •Karnofsky Performance Status (KPS) ≥ 60%
- •Life expectancy > 12 weeks.
- •No severe hematological, cardiovascular, liver or kidney diseases.
- •If the patient is a sexually active female of childbearing potential or if the patient is a sexually active male whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of before the C5252 infusion.
- •Capable of understanding and complying with protocol requirements.
排除标准
- •Inability to undergo MRI examination for any reason.
- •Active hemorrhage observed before enrollment.
- •Imaging test: a. lesion located in non-cerebral regions; b. there are other lesions outside target tumor cavity; c. extra-cranial metastasis.
- •Tumor lesion locates in ventricular system or there is a clear perforation between the tumor cavity and the ventricle after tumor resection.
- •History of encephalitis, multiple sclerosis or other central nervous system infections
- •Treated with steroid hormones and/or more than 5 mg dexamethasone per day or other immunosuppressive drugs for systemic treatment within 4 weeks.
- •Persistent or active infection, and cannot be controlled by treatment.
- •Subjects with bleeding tendency or need to take anticoagulant drugs, antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs) and are unable to discontinue.
- •Uncontrolled disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris.
- •Other malignant tumor within 5 years.
- •Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period.
- •In the period of recurrent herpes simplex virus infection, with corresponding clinical manifestations.
- •Systemic use (other than topical) of anti-HSV drugs
- •Prior treatment with any oncolytic virus, cell therapy or gene therapy.
- •Participants have a history of splenectomy, organ transplantation, bone marrow transplantation or stem cell transplantation
- •Prior antitumor treatment with intracranial implants, such as Carmustine.
- •Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the C5252 prescription, including glycerol.
- •Developed ≥Grade 3 irAE during previous immunotherapy
- •History of frequent drug use (including "recreational use") or drug abuse (including alcohol abuse) within one year prior to signing the informed consent form.
- •Other situation that PI consider subjects not appropriate to participate in the study.
研究组 & 干预措施
Herpes Virus C5252 Injection
Experimental
干预措施: Herpes Virus C5252 Injection (Biological)
结局指标
主要结局
Phase I: Incidence of adverse event
时间窗: Up to 30 days after completion of treatment
TEAE, SAE, DLT, AESI during treatment period
Phase I: Determine the MTD/RP2D
时间窗: up to 4 weeks
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
Phase II: Overall Survival
时间窗: Up to 2 years
The overall survival for each patient receiving C5252 will be calculated.
Phase II: OS rate
时间窗: Up to 2 years after first dose
OS rate at 6, 12, 18 and 24 months after first study dose
次要结局
未报告次要终点
研究者
研究点 (2)
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