<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/NCT03013712</url>
  </required_header>
  <id_info>
    <org_study_id>CARTEPC-001</org_study_id>
    <nct_id>NCT03013712</nct_id>
  </id_info>
  <brief_title>A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer</brief_title>
  <acronym>CARTEPC</acronym>
  <official_title>A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Chengdu Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Chengdu Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T&#xD;
      Cells infusion for EpCAM positive Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being conducted to evaluate the safety and efficacy of Chimeric antigen&#xD;
      receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In&#xD;
      the research, the investigators design a novel CAR consists of a EpCAM targeting antibody&#xD;
      scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T&#xD;
      cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell&#xD;
      infusion, the patients will be subjected to preconditioning treatment. The infusion dose is&#xD;
      (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the&#xD;
      situation of individual CAR-T cells preparation. The way of infusion is vascular&#xD;
      interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to&#xD;
      30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion,&#xD;
      the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T&#xD;
      cells and efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival time of anti-EpCAM CAR T cells in vivo</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Detect the existence of CAR-T cells in the blood of participants through flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Esophageal Carcinoma</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Hepatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>CAR-T cell immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CAR-T cell immunotherapy</intervention_name>
    <description>This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.</description>
    <arm_group_label>CAR-T cell immunotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Relapsed or refractory EpCAM positive cancer.&#xD;
&#xD;
          2. KPS &gt; 60.&#xD;
&#xD;
          3. Life expectancy&gt;3 months.&#xD;
&#xD;
          4. Gender unlimited, age from 18 years to 80 years.&#xD;
&#xD;
          5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.&#xD;
&#xD;
          6. Acceptable organ function Hematology:&#xD;
&#xD;
               -  Absolute neutrophil count greater than 800/mm^3 without the support of&#xD;
                  filgrastim.&#xD;
&#xD;
               -  White blood cell (WBC) (&gt; 2000/mm^3).&#xD;
&#xD;
               -  Platelet count greater than 50,000/mm^3.&#xD;
&#xD;
               -  Hemoglobin greater than 9.0 g/dl.&#xD;
&#xD;
          7. No other serious diseases(autoimmune disease, immunodeficiency etc.).&#xD;
&#xD;
          8. Adequate cardiac function (LVEF ≥ 40%).&#xD;
&#xD;
          9. No other tumors.&#xD;
&#xD;
         10. Patients volunteer to participate in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to cytokines.&#xD;
&#xD;
          2. Uncontrolled active infection.&#xD;
&#xD;
          3. Acute or chronic GVHD.&#xD;
&#xD;
          4. MODS.&#xD;
&#xD;
          5. Treated with T cell inhibitor.&#xD;
&#xD;
          6. HIV affected.&#xD;
&#xD;
          7. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao-an Li, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital of Chengdu Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Zhou, PhD</last_name>
    <phone>+86-18981941992</phone>
    <email>zqlvzy319@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>IEC of Chengdu Medical College</name>
      <address>
        <city>Chendu</city>
        <zip>610500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao-an Li, post doctor</last_name>
      <phone>+8613680868858</phone>
      <email>435445611@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03013712
org study id: CARTEPC-001
nct id: NCT03013712
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T
      Cells infusion for EpCAM positive Cancer.
This study is being conducted to evaluate the safety and efficacy of Chimeric antigen
      receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In
      the research, the investigators design a novel CAR consists of a EpCAM targeting antibody
      scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T
      cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell
      infusion, the patients will be subjected to preconditioning treatment. The infusion dose is
      (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the
      situation of individual CAR-T cells preparation. The way of infusion is vascular
      interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to
      30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion,
      the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T
      cells and efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
time frame: up to 24 months
description: Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
measure: Survival time of anti-EpCAM CAR T cells in vivo
time frame: up to 24 months
description: Detect the existence of CAR-T cells in the blood of participants through flow cytometry
measure: Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
time frame: up to 24 months
description: Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1
arm group label: CAR-T cell immunotherapy
arm group type: Experimental
description: Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.
intervention type: Biological
intervention name: CAR-T cell immunotherapy
description: This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
arm group label: CAR-T cell immunotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiao-an Li, PhD
role: Study Chair
affiliation: First Affiliated Hospital of Chengdu Medical College
last name: Yan Zhou, PhD
phone: +86-18981941992
email: zqlvzy319@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Esophageal Neoplasms
mesh term: Carcinoma, Hepatocellular
mesh term: Immunomodulating Agents
sharing ipd: No