NCT05830240招募中早期 1 期
A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer
Shanghai Yunying Medical Technology1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Systemic immune response
研究概览
简要总结
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
- •Age 18 to 75 years.
- •No absolute or relative centasis contraindiction，have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
- •No severe functinonal falure of heart, brain, liver, kidney and lung.
- •Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
- •No evidence of clinically significant immunosuppression.
- •Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period:
- •White Blood Cell (WBC)≥3.0×10^9/L；
- •Absolute Lymphocyte Count (ANC)≥1.5×10^9/L;
- •Platelet≥100×10^9/L；
- •Prothrombin time (PT) or activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
- •Serum Creatinine (Scr)≤1.5×ULN
- •Alanine aminotransferase(AST/ALT) ≤3×ULN;
- •Total Bilirubin(TBIL)≤1.5×ULN.
- •Be able to understand and sign the informed consent document;
- •Be able to stick to follow-up visit plan and other requirements in the agreement.
- •Exclusion Criteria.
- •With a history of allergy to similar drugs.
- •With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors.
- •pregnancy, breast feeding.
- •Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
- •Impaired function of important organs or a history of organ transplantation.
- •Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks.
- •Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose.
- •Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
- •Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g.
- •Patients with past history of type I diabetes mellitus.
- •Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
- •Patients with active bleeding or severe coagulation dysfunction.
- •Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
排除标准
- 未提供
研究组 & 干预措施
R130 Treatment Group
Experimental
Every 7-14 days,1-2 ml R130 （concentration of 1x10^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory head and neck cancer
干预措施: Recombinant oncolytic herpes simplex virus type 1 (R130) (Drug)
结局指标
主要结局
Systemic immune response
时间窗: Up to 6 months
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa，IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Safety Profile Measured by Grade ≥3 CTCAE v5.0
时间窗: Up to 6 months
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
次要结局
- Disease Assessment for Disease Control Rate(Every 10 weeks for 12 months)
- Disease Assessment for Duration of Response(Every 10 weeks for 12 months)
- Quality of Life Assessment(Every 6 weeks for 12 months)
研究者
研究点 (1)
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