Safety, immunogenicity and clinical response of sig-HELP-E6SH/E7SH-kdel, injected in the epidermis by DNA tattoo, in HPV16-positive vulvar intraepithelial neoplasia: a phase I/II study - HPV16 E6-E7

KI-AV0 个研究点开始时间: 2016年1月18日最近更新: 2016年9月12日

适应症

试验速览

暂无简介。

•Age above 18 years
•Willing and able to undergo the planned study procedures
•Written informed consent
•Histologically proven visible uVIN lesion (histology =3 months prior to enrolment and at least 6 weeks after last treatment)
•HPV16-positive VIN lesion (to be determined on archival tumour tissue (=10 years old); if not available a new biopsy will be required)
•No indication of an active infectious disease: HIV, HCV and HBV negative
•No history of autoimmune disease or systematic undercurrent disease which might affectimmunocompetence
•Adequate bone marrow (WBC > 3.0/nL, platelets > 100/nL), renal function (creatinine clearance > 40 mL/min), and liver function (bilirubin < 1.5 x ULN, normal blood coagulation)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Prior treatment with anti-HPV agents
•Participation in a study with another investigational drug within 30 days prior to enrolment in this study
•Severe cardiac, respiratory, or metabolic disease
•Use of systemic steroids or other immunosuppressive drugs
•Use of oral anticoagulant drugs (except ascal)
•Severe infections requiring antibiotics
•Any treatment for the uVIN lesion within 6 weeks prior to the enrolment (including imiquimod)
•Lactation or pregnancy (if applicable)
•Not willing to take adequate contraceptive measures (if applicable)

发起方

KI-AV