Phase I/II open-label clinical trial of autologous Epstein-Barr virus-specific T cell therapy as consolidative treatment following chemotherapy for metastatic EBV-associated nasopharyngeal carcinoma.

QIMR Berghofer Medical Research Institute0 个研究点目标入组 18 人开始时间: 2013年8月6日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•1. Age 18 years or above
•2 . Histologically proven NPC (non-keratinising or undifferentiated carcinoma) at first diagnosis
•3. Provision of Informed consent. Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter.
•4. First relapse of NPC; either metastatic disease or loco-regionally recurrence that is not resectable
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
•6. Life expectancy of at least 6 months, as determined by the clinical investigator
•7. Adequate haematological and biochemical function
•8. Completion of a medical questionnaire
•9. Suitable to commence treatment, or currently receiving treatment , for metastatic disease or recurrent loco-regional disease not amenable to surgery

•1. EBV negative tumour
•2 . Serological evidence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis infection (N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion)
•3. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction)
•4.. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
•5. Inability to provide informed consent, including patients with severe cognitive impairment, intellectual disability or mental illness
•6. Prior cancers, except those diagnosed greater than 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5 percent, or successfully treated nonmelanoma skin cancer, or carcinoma in situ of the cervix.
•7. Currently receiving immunosuppressive therapy, including corticosteroids. At the discretion of the clinical investigator the patient can receive anti-emetics
•8. Pregnant, lactating, or unwilling to use adequate contraception

发起方