ACTRN12609000338268已完成1 期
Phase I trial to assess safety of autologous Human Cytomegalovirus (HCMV)-specific T cell therapy for glioblastoma multiforme
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age 18 years or above.
- •2. Geographically accessible for follow up
- •3. Informed consent.
- •4. ECOG (Eastern Cooperative Oncology Group) performance status 0, 1, 2 or 3
- •5. Life expectancy of at least 3 months
- •6. Previous histological diagnosis of GBM (WHO (World Health Organization) grade IV) and radiological and/or clinical evidence of tumour progression or recurrence
排除标准
- •1. HCMV negative serology
- •2. Positive serology for HIV (Human Immunodefficiency Virus)
- •3. Serology indicating active HBV infection or carrier status for HBV.
- •4. Serology indicating active HCV infection
- •5. Significant non–malignant disease
- •6. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
- •7. Prior cancers, except those diagnosed >5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of < 5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix.
- •8. Receiving immunosuppressive therapy, including corticosteroids.
- •9. Pregnancy, or unwilling to use adequate contraception.
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