NCT05557240招募中不适用
Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年9月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and toleration
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.
详细描述
This is a signelcenter, open-label, single arm, first-in-human phase I trial to investigate the safety, feasibility and immune response of the novel NeoPep Vaccine in patients with newly diagnosed GB.
Primary Endpoints:
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
Secondry Endpoints:
- Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.
- Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
- Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of subject to understand and the willingness to sign written informed consent for study participation;
- •Patients with newly diagnosed high-grade glioma confirmed by histopathological and imaging evaluation;
- •Gross total resection (as defined by less than 1 cm2 residual tumor mass on the largest perpendicular axes in post-operative scan taken within 48 h post-surgery; standard MRI conformable to the present national and international guidelines is sufficient)；
- •At least 0.5 g tumor tissue freshly cryopreserved during surgery，and could provide adequate amounts of PBMC；
- •Patient is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ cycles;
- •Life expectancy > 9 months;
- •Sufficient tumor tissue samples and peripheral blood samples can be obtained for sequencing analysis, or whole exome sequencing and RNA sequencing of tumor tissue samples and peripheral blood samples have been obtained, and the sequencing data meet the prediction requirements;
- •Consent of women and men of reproductive age to use adequate and effective contraception during clinical trials;
- •Normal laboratory values for hematology, liver and renal function (serum creatinine).In detail the following values apply as inclusion criteria:
- •White blood cell count (WBC) ≥3.0×109/L；
- •Absolutely neutrophil count≥1.0×109/L；
- •Platelet count≥80×109/L；
- •Hemoglobin content≥90g/L；
- •Serum creatinine≤1.5 ULN or Creatinine clearance rate≥40 mL/min;
- •TBil(total bilirubin)≤1.5 x ULN;
- •Aspartic transaminase(AST)≤2.5x ULN or Alanine aminotransferase（ALT）≤2.5x ULN；Patients with liver metastases must have ≤5x ULN;
- •Blood coagulation function :INR≤1.5x ULN；pT and APTT≤1.5x ULN;
- •Urine protein< 2 +;if Urine protein≥2+,24-hour urinary protein must be less than 1g.
排除标准
- •Patients treated with immunosuppressive agents (e.g., cyclosporin CsA, tacrolimus, rapamycin, azathioprine, etc.) within the previous month; Other immunotherapy within 3 months;
- •History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years;
- •Participated in other clinical trials within 30 days prior to screening;
- •Have a history of severe allergy or allergic constitution;
- •Patients who have undergone splenectomy;
- •Persons with primary or secondary immunodeficiency diseases (e.g. AIDS);Patients with autoimmune diseases;
- •Patients who received multiple oral, intramuscular, or intravenous corticosteroids within 30 days before the first dose; However, patients who received a single oral, intramuscular, or intravenous dose of dexamethasone of 5mg or less (or another hormone of equivalent potency) 14 days before the first dose were allowed; Allow inhaled corticosteroids to treat respiratory insufficiency (e.g., chronic obstructive pulmonary disease), or topical steroids;
- •Patients with uncontrollable seizures, central nervous system disorders, or psychotic loss of cognition;
- •Uncontrolled central nervous system metastases;
- •Patients had a history of chronic alcohol or drug abuse in the 6 months before screening;
- •With unstable systemic disease, such as active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within one year, etc. ;
- •According to this procedure, the number of candidate neoantigens that can be used to make personalized vaccines is less than 20;
- •The investigator did not consider it appropriate to participate in this study.
研究组 & 干预措施
NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ
Experimental
干预措施: NeoPep Vaccine1 plus Poly-ICLC (Drug)
NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ
Experimental
干预措施: NeoPep Vaccine2 plus Poly-ICLC (Drug)
结局指标
主要结局
Safety and toleration
时间窗: Continously for about 40 weeks plus follow-up
Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment
次要结局
- Overall survival(OS)(till 24 months of vaccination)
- T-cell immune response(till 24 months of vaccination)
- Progression-free survival（PFS）(till 12 months of vaccination)
研究者
LiangGao
Neurosurgery department
Shanghai 10th People's Hospital
研究点 (1)
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