<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195089</url>
  </required_header>
  <id_info>
    <org_study_id>UMT2013-BLS-ILB-E710c</org_study_id>
    <secondary_id>12591</secondary_id>
    <nct_id>NCT02195089</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioLeaders Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioLeaders Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for&#xD;
      the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to&#xD;
      see the inducement of Cytotoxic T Lymphocyte.&#xD;
&#xD;
      The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed&#xD;
      by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c&#xD;
      1000mg for 8 weeks followed by 1 week observation The Third treatment group will be&#xD;
      administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth&#xD;
      treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by&#xD;
      8 weeks observation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1 : Safety</measure>
    <time_frame>up to 9 weeks</time_frame>
    <description>Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2a : Regression rate</measure>
    <time_frame>screening and 9 weeks(option), 16 weeks.</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reid Colposcopic Index</measure>
    <time_frame>Phase 1 : up to 9 weeks</time_frame>
    <description>Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reid Colposcopic Index</measure>
    <time_frame>Phase 2a : up to 16 weeks</time_frame>
    <description>Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum anti-E7 antibody</measure>
    <time_frame>1 week, 9 weeks, 16 weeks</time_frame>
    <description>Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>BLS_ILB_E710c 500mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BLS_ILB_E710c 500mg&#xD;
Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 &amp; 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLS_ILS_E710c 1000mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BLS_ILS_E710c 1000mg&#xD;
Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 &amp; 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLS_ILS_E710c 1500mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BLS_ILS_E710c 1500mg&#xD;
Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 &amp; 8)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLS_ILS_E710c 500mg</intervention_name>
    <description>- 2 capsules per day for 20 days (week 1,2,4 &amp; 8)</description>
    <arm_group_label>BLS_ILB_E710c 500mg</arm_group_label>
    <other_name>CIN3 Theraputic Vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLS_ILB_710c 1000mg</intervention_name>
    <description>- 4 capsules per day for 20 days (week 1,2,4 &amp; 8)</description>
    <arm_group_label>BLS_ILS_E710c 1000mg</arm_group_label>
    <other_name>CIN3 Theraputic Vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLS_ILS_E710c 1500mg</intervention_name>
    <description>- 6 capsules per day for 8 weeks (week 1,2,4 &amp; 8)</description>
    <arm_group_label>BLS_ILS_E710c 1500mg</arm_group_label>
    <other_name>CIN3 Theraputic Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal patients between age of 20 and 50.&#xD;
&#xD;
          -  Patients with cervical intraepithelial neoplasia 3(CIN3).&#xD;
&#xD;
          -  Only infection with HPV type 16.&#xD;
&#xD;
          -  Patients with Capable of observation of all of lesions by Colposcopy biopsy.&#xD;
&#xD;
          -  Be informed of the nature of the study and will give written informed consent.&#xD;
&#xD;
          -  Be agree with contraception during study&#xD;
&#xD;
          -  White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet&#xD;
             over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm^3&#xD;
&#xD;
          -  Normal for EKG(Electrocardiography)&#xD;
&#xD;
          -  AST/ALT : 2.5 times less than normal range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.&#xD;
&#xD;
          -  Patient that has medical history of hypersensitivity about Food containing Lactic acid&#xD;
             bacteria or Lactic acid bacteria medication.&#xD;
&#xD;
          -  Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage,&#xD;
             meningitis etc.)&#xD;
&#xD;
          -  Investigational product within three months before the start of the drug&#xD;
             administration to patients treated with other test drug.&#xD;
&#xD;
          -  Patient with Chronic pancreatitis currently or Patients diagnosed with acute&#xD;
             pancreatitis.&#xD;
&#xD;
          -  Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal&#xD;
             tumors, ulcers, bleeding, perforation etc.&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patient with HBV or HCV infection (except for Asymptomatic)&#xD;
&#xD;
          -  Patient that Investigator judge&#xD;
&#xD;
          -  Deemed inappropriate for researchers to judge the patient&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Kwan Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tae Jin Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kwandong University College of Medicine Cheil Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jong Sup Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University, Korea Seoul St Mary's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chi-Heum Cho, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Dongsan Medical Center of Keimyung University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jong Hyeok Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Dongsan Medical Center of Keimyung University</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwandong University College of Medicine Cheil Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>100-380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University, Korea Seoul St Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Treatment of Cervical Intraepithelial Neoplasia(CIN3)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195089
org study id: UMT2013-BLS-ILB-E710c
secondary id: 12591
nct id: NCT02195089
lead sponsor: 
has dmc: No
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).
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
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1 : Safety
time frame: up to 9 weeks
description: Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
measure: Phase 2a : Regression rate
time frame: screening and 9 weeks(option), 16 weeks.
description: 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
measure: Reid Colposcopic Index
time frame: Phase 1 : up to 9 weeks
description: Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
measure: Reid Colposcopic Index
time frame: Phase 2a : up to 16 weeks
description: Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
measure: Serum anti-E7 antibody
time frame: 1 week, 9 weeks, 16 weeks
description: Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.
arm group label: BLS_ILB_E710c 500mg
arm group type: Experimental
description: Drug: BLS_ILB_E710c 500mg
Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 & 8)
arm group label: BLS_ILS_E710c 1000mg
arm group type: Experimental
description: Drug: BLS_ILS_E710c 1000mg
Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 & 8)
arm group label: BLS_ILS_E710c 1500mg
arm group type: Experimental
description: Drug: BLS_ILS_E710c 1500mg
Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 & 8)
intervention type: Drug
intervention name: BLS_ILS_E710c 500mg
description: - 2 capsules per day for 20 days (week 1,2,4 & 8)
arm group label: BLS_ILB_E710c 500mg
other name: CIN3 Theraputic Vaccine
intervention type: Drug
intervention name: BLS_ILB_710c 1000mg
description: - 4 capsules per day for 20 days (week 1,2,4 & 8)
arm group label: BLS_ILS_E710c 1000mg
other name: CIN3 Theraputic Vaccine
intervention type: Drug
intervention name: BLS_ILS_E710c 1500mg
description: - 6 capsules per day for 8 weeks (week 1,2,4 & 8)
arm group label: BLS_ILS_E710c 1500mg
other name: CIN3 Theraputic Vaccine
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jae-Kwan Lee, MD, PhD
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Tae Jin Kim, MD, PhD
role: Principal Investigator
affiliation: Kwandong University College of Medicine Cheil Hospital
last name: Jong Sup Park, MD, PhD
role: Principal Investigator
affiliation: The Catholic University, Korea Seoul St Mary's Hospital
last name: Chi-Heum Cho, MD, PhD
role: Principal Investigator
affiliation: The Dongsan Medical Center of Keimyung University
last name: Jong Hyeok Kim, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Dysplasia
mesh term: Vaccines