NCT04943718Unknown1 期
Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- incidences of advent events and severe advent events
研究概览
简要总结
A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.
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
- •age 18-70;
- •signed inform consent;
- •patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
- •patients' tumor tissue should have a high mutation load(>10 TMB); be genetically unstable; at least have 10 neoantigens;
- •should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
- •at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;
- •have not received any immune therapy;
- •at least have one measurable lesion;
- •KPS >60;
- •estimated survival > 3 months
- •patients should have adequate organ and bone marrow function;
排除标准
- •female patient is breastfeeding or pregnant;
- •known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);
- •known history of Graft-Versus-Host Disease (GVHD);
- •participation in gene therapy;
- •other malignancy;
- •systemic disease: i.e., severe infection; HIV;
- •other conditions upon investigator's judgement;
结局指标
主要结局
incidences of advent events and severe advent events
时间窗: from initiation of study treatment to 28 weeks post-vaccination
would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)
次要结局
- object response rate (ORR) according to iRANO criteria(from initiation of study treatment to 24 weeks post-vaccination (last shot))
- progression free survival (PFS)(up to 48 weeks post-vaccination(last shot))
- overall survival (OS)(up to 48 weeks post-vaccination(last shot))
- immune response based on the criteria encoded by GRT-C903 and GRT-R904(Baseline to end of treatment (up to approximately 12 months))
研究者
Qingtang Lin
Director, glioma immunotherapy program
Xuanwu Hospital, Beijing
研究点 (1)
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