A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose
研究概览
简要总结
The purpose of this study is to examine the use of activated T cells (ATCs) to assess the safety and tolerability of autologous activated T cells, as measured by the number of Grade 3 or higher toxicities, the number of serious adverse events, and treatment-related toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of overall survival, rate of progression-free survival, health-related quality of life parameters, overall response rate, immune response, and tumor stem cell antigen expression.
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
- •Recurrent glioblastoma
- •HLA-A1 and HLA-A2 positive
- •Complete resection of tumor
排除标准
- •Clinically significant pulmonary, cardiac or other systemic disease
- •Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed.
- •Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition.
- •Known history of Hepatitis B or Hepatitis C
- •Allergy to Dimethyl sulfoxide (DMSO)
- •Allergy to gentamicin
研究组 & 干预措施
Activated T cells
干预措施: Activated T cells (Biological)
结局指标
主要结局
Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose
时间窗: From start of study treatment until End of Study, an average of 2 months
Recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5
次要结局
- Overall Survival (OS)(From date of enrollment to date of death of any cause or withdrawal of consent, whichever came first. Assessed up to 3 years.)
- Progression-Free Survival (PFS)(From start of study treatment, until confirmation of disease progression or withdrawal of consent, whichever came first. Assessed up to 3 years.)
- Health-related quality of life parameters(From baseline visit to End of Study, an average of 2 months)
- Tumor stem cell antigen expression(At Baseline visit and at time of recurrence. Assessed up to 3 years.)
- Immune Response(At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2)
- Overall Response Rate (ORR)(From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.)
研究者
Jeremy Rudnick, M.D
Co-Director, Neuro-Oncology
Cedars-Sinai Medical Center