A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.

Exclusion Criteria

• •1. Patients with a history of malignant tumor, excluding Head and neck squamous cell carcinoma, within 3 years prior to the screening (However, patients who are judged by investigator to have been cured of Basal cell carcinoma (BCC) / Squamous cell carcinoma (SCC) of the skin, localized prostate cancer, papillary thyroid cancer, or cervical intraepithelial neoplasia (CIN) are able to enroll.)
• •2. Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
• •3. Patients having below cardiovascular disease at the time of the screening process.
• •① Myocardial infarction or Unstable angina within 6 months prior to the first IP administration (baseline).
• •* Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).
• •* Ventricular arrhythmia requiring treatment. ④ Severe conduction disorder (e.g. 3rd degree AV block) ⑤ Uncontrolled hypertension according to the judgement by investigator.
• •4. Patients who have confirmed clinically significant symptoms or uncontrolled central nervous system, brain metastasis, or carcinomatous meningitis (However, patients who have not confirmed the progression disease for at least 4 weeks after central nervous system or metastatic brain treatment and have not required treatment using steroid or other meditation within 7 days prior to the IP administration can be enrolled.)
• •5. Patients with a history or confirmed active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, or T cell lymphoma) after receiving systemic treatment (e.g. disease-modifying agent, corticosteroid or immunosuppressive drug) \[However, alternative treatment (thyroxine, insulin, physiologic corticosteroid alternative treatment due to dysfunction of adrenal gland or pituitary gland) are not considered as systemic treatments.\]
• •6. Patients who are unable to collect the blood for production of the IP, according to the judgement of investigator, due to thromboembolism disease or bleeding diatheses.
• •7. Patients with a positive human immunodeficiency virus (HIV) test result
• •8. Patients with active hepatitis B or C according to the hepatitis B virus (HBV) and hepatitis C virus (HCV) test result.
• •① Patients positive for HBsAg and HBV DNA.
• •② Patients positive for anti-HCV and HCV RNA.
• •9. Patients with autoimmune disease or history of chronic or recurrent autoimmune diseases.
• •10. Patients with a history of organ transplantation.
• •11. Hematopoietic stem cell transplantation (HSCT) patients.
• •12. Patients who have confirmed severe or uncontrolled active inflammation within 12 weeks prior to screening process.
• •13. Patients with a history of hypersensitivity to the components of IP.
• •14. Patients who have administrated a leukocyte product within 12 weeks prior to screening process.
• •16. Patients who have administrated live-vaccine or live attenuated vaccine within 4 weeks prior to baseline.
• •17. Patients who have administrated immunosuppressant within 2 weeks prior to baseline. (However, usage corresponding to the following immunosuppressant is allowed.)
• •* Steroid for nasal cavity, aspiration, topical, or local site (e.g. Intra-articular injection)
• •* Prednisolone 10 mg/day or systemic corticosteroid at a physiologic dose that does not exceed the equivalent amount.
• •* Steroids used for pretreatment of hypersensitivity (e.g. pretreatment of CT)
• •18. Patients who meet the following laboratory test standards in the screening test
• •* ANC \< 1,500/mm³
• •* Platelet count \< 75,000/mm³
• •* Hemoglobin \< 9.0 g/dL (If the hemoglobin recovers above 9.0g/dL during the screening period, the patient is eligible for enrollment. However, blood transfusions within 7 days before screening to meet that standard is not allowed.)
• •* Serum creatinine \>1.5 × ULN
• •* Total bilirubin \>1.5 × ULN
• •* AST or ALT \>2.5 × ULN (If liver metastasis confirmed \>5 × ULN)
• •19. Pregnant or lactating women
• •① Patients who have participated in a clinical trial of immune therapeutic vaccine within 1 year before the screening or in an immunotherapy clinical trial within 6 weeks before the screening.
• •② Patients with adverse drug reaction of Grade 2 or higher clearly associated with a previously participated immunotherapy clinical trial.