Clinical trial NCT02195089: Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Official title: A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Treatment of Cervical Intraepithelial Neoplasia(CIN3)
Lead sponsor: BioLeaders Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

Detailed description: This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal patients between age of 20 and 50.
* Patients with cervical intraepithelial neoplasia 3(CIN3).
* Only infection with HPV type 16.
* Patients with Capable of observation of all of lesions by Colposcopy biopsy.
* Be informed of the nature of the study and will give written informed consent.
* Be agree with contraception during study
* White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm\^3
* Normal for EKG(Electrocardiography)
* AST/ALT : 2.5 times less than normal range

Exclusion Criteria:

* Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
* Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
* Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
* Investigational product within three months before the start of the drug administration to patients treated with other test drug.
* Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
* Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
* Pregnant or lactating women
* Patient with HBV or HCV infection (except for Asymptomatic)
* Patient that Investigator judge
* Deemed inappropriate for researchers to judge the patient

Primary outcomes:
measure: Phase 1 : Safety
timeFrame: up to 9 weeks
measure: Phase 2a : Regression rate
timeFrame: screening and 9 weeks(option), 16 weeks.
Secondary outcomes:
measure: Reid Colposcopic Index
timeFrame: Phase 1 : up to 9 weeks
measure: Reid Colposcopic Index
timeFrame: Phase 2a : up to 16 weeks
measure: Serum anti-E7 antibody
timeFrame: 1 week, 9 weeks, 16 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: The Dongsan Medical Center of Keimyung University
city: Seoul
country: Korea, Republic of
facility: Kwandong University College of Medicine Cheil Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University, Korea Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jae-Kwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwandong University College of Medicine Cheil Hospital
name: Tae Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University, Korea Seoul St Mary's Hospital
name: Jong Sup Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Dongsan Medical Center of Keimyung University
name: Chi-Heum Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jong Hyeok Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park YC, Ouh YT, Sung MH, Park HG, Kim TJ, Cho CH, Park JS, Lee JK. A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3. J Gynecol Oncol. 2019 Nov;30(6):e88. doi: 10.3802/jgo.2019.30.e88.