Phase I trial to assess the safety and tolerability of autologous CMV-specific T cells as adjuvant therapy for primary glioblastoma multiforme

QIMR Berghofer Medical Research Institute0 个研究点目标入组 20 人开始时间: 2015年6月25日最近更新: 2021年10月18日

适应症

试验速览

暂无简介。

•1. Age 18 years or above
•2. Ability to provide informed consent.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at time of screening
•4. Life expectancy of at least 6 months
•5. Histological diagnosis of primary GBM (WHO grade IV)
•6. CMV-positive serology or positive staining for CMV in tumour tissue

•1. Markers of active HBV, HCV, HIV, HTLV I and II or syphilis infection* (presence of HbsAg, HCV antibody, HIV antibody, antibodies to HTLV I and II and positive serological test for syphilis, or positive nucleic acid testing [NAT] for HIV, HBV or HCV)
•2. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction)
•3. Psychiatric, addictive or any conditions that may compromise the ability to participate in this trial, as assessed by the Clinical Investigator
•4. 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.
•5. Receiving immunosuppressive therapy, except dexamethasone as given for normal management of symptoms related to the brain tumour and its treatment
•6. Women who are pregnant, lactating, or unwilling to use adequate contraception
•* N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion.

发起方