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CompletedNCT02195089Updated Apr 19, 2016

Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

A Phase 1/2 interventional study of BLS_ILS_E710c 500mg and BLS_ILB_710c 1000mg in Cervical Intraepithelial Neoplasia, sponsored by BioLeaders Corporation. Completed at 5 sites in Korea, Republic of. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by BioLeaders Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study 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).

Read the 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

02

Conditions studied

  • Cervical Intraepithelial Neoplasia

Keywords

  • Treatment of Cervical Intraepithelial Neoplasia(CIN3)
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

BioLeaders Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    BLS_ILB_E710c 500mg

    * Drug: BLS_ILB_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)

    Drug: BLS_ILS_E710c 500mg

  • Experimental
    BLS_ILS_E710c 1000mg

    * Drug: BLS_ILS_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)

    Drug: BLS_ILB_710c 1000mg

  • Experimental
    BLS_ILS_E710c 1500mg

    * Drug: BLS_ILS_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)

    Drug: BLS_ILS_E710c 1500mg

Interventions

  • DrugBLS_ILS_E710c 500mg

    - 2 capsules per day for 20 days (week 1,2,4 \& 8)

    Also known as: CIN3 Theraputic Vaccine

  • DrugBLS_ILB_710c 1000mg

    - 4 capsules per day for 20 days (week 1,2,4 \& 8)

    Also known as: CIN3 Theraputic Vaccine

  • DrugBLS_ILS_E710c 1500mg

    - 6 capsules per day for 8 weeks (week 1,2,4 \& 8)

    Also known as: CIN3 Theraputic Vaccine

06

What researchers measure

Primary outcomes

  1. Phase 1 : Safety

    Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0

    Time frame: up to 9 weeks

  2. Phase 2a : Regression rate

    Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal

    Time frame: screening and 9 weeks(option), 16 weeks.

Secondary outcomes

  1. Reid Colposcopic Index

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.

    Time frame: Phase 1 : up to 9 weeks

  2. Reid Colposcopic Index

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks

    Time frame: Phase 2a : up to 16 weeks

  3. Serum anti-E7 antibody

    Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

    Time frame: 1 week, 9 weeks, 16 weeks

07

Study locations

5 sites
  • The Dongsan Medical Center of Keimyung University
    Daegu, 700-712, Korea, Republic of
  • Kwandong University College of Medicine Cheil Hospital
    Seoul, 100-380, Korea, Republic of
  • The Catholic University, Korea Seoul St Mary's Hospital
    Seoul, 137-701, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 152-703, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 31576684 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02195089
Lead sponsor
BioLeaders Corporation
Responsible party
Sponsor
First posted
Jul 21, 2014
Start date
Mar 2014
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Apr 19, 2016

Study contacts

Jae-Kwan Lee, MD, PhD
principal investigator · Korea University Guro Hospital
Tae Jin Kim, MD, PhD
principal investigator · Kwandong University College of Medicine Cheil Hospital
Jong Sup Park, MD, PhD
principal investigator · The Catholic University, Korea Seoul St Mary's Hospital
Chi-Heum Cho, MD, PhD
principal investigator · The Dongsan Medical Center of Keimyung University
Jong Hyeok Kim, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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