<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/NCT03799913</url>
  </required_header>
  <id_info>
    <org_study_id>MESO</org_study_id>
    <nct_id>NCT03799913</nct_id>
  </id_info>
  <brief_title>MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer</brief_title>
  <official_title>A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hrain Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen&#xD;
      receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives&#xD;
&#xD;
      1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with&#xD;
      MESO-positive ovarian cancer.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.&#xD;
&#xD;
        2. To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">April 10, 2019</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>Early Phase 1</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>Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0</measure>
    <time_frame>1 years post infusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm</measure>
    <time_frame>12 months post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progress Free Survival (PFS) after administration</measure>
    <time_frame>12 months post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CAR-positive T cells in circulation</measure>
    <time_frame>12 months post infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of PD1 antibody in serum</measure>
    <time_frame>12 months post infusion</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>anti-MESO CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>anti-MESO CAR-T cells</intervention_name>
    <description>Retroviral vector-transduced autologous T cells to express anti-MESO CARs</description>
    <arm_group_label>anti-MESO CAR-T cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>30mg/m2/d</description>
    <arm_group_label>anti-MESO CAR-T cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>300mg/m2/d</description>
    <arm_group_label>anti-MESO CAR-T cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 70 Years Old, female;&#xD;
&#xD;
          2. Expected survival &gt; 12 weeks;&#xD;
&#xD;
          3. Clinical performance status of ECOG score 0-2;&#xD;
&#xD;
          4. Patients who have previously been treated with second- line or more lines of standard&#xD;
             treatment are not effective (No remission or recurrence after remission);&#xD;
&#xD;
          5. At least one measurable tumor foci according to RECIST standard 1.1 ;&#xD;
&#xD;
          6. Positive Mesothelin expression in tumor tissues;&#xD;
&#xD;
          7. Creatinine ≤ 1.5×ULN;&#xD;
&#xD;
          8. ALT and AST ≤ 3×ULN;&#xD;
&#xD;
          9. Total bilirubin ≤ 2×ULN;&#xD;
&#xD;
         10. Hemoglobin≥90g/L;&#xD;
&#xD;
         11. Absolute counting of neutrophils≥1000uL ;&#xD;
&#xD;
         12. Absolute counting of lymphocytes&gt;0.7×10^9/L;&#xD;
&#xD;
         13. Counting of Platelet≥75000/uL;&#xD;
&#xD;
         14. The venous access required for collection can be established without contraindications&#xD;
             for leukocyte collection;&#xD;
&#xD;
         15. Able to understand and sign the Informed Consent Document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Accompanied by other uncontrolled malignant tumors;&#xD;
&#xD;
          2. Active hepatitis B, hepatitis C, syphilis, HIV infection;&#xD;
&#xD;
          3. Suffering severe cardiovascular or respiratory disease;&#xD;
&#xD;
          4. Any other diseases could affect the outcome of this trial;&#xD;
&#xD;
          5. Any affairs could affect the safety of the subjects or outcome of this trial;&#xD;
&#xD;
          6. Pregnant or lactating women, or patients who plan to be pregnancy during or after&#xD;
             treatment;&#xD;
&#xD;
          7. There are active or uncontrollable infections (except simple urinary tract infections&#xD;
             or upper respiratory tract infections) that require systemic therapy 14 days or 14&#xD;
             days prior to assignment;&#xD;
&#xD;
          8. Patients who are accounted by researchers to be not appropriate for this test;&#xD;
&#xD;
          9. Received CAR-T treatment or other gene therapies before assignment;&#xD;
&#xD;
         10. Subject suffering disease affects the understanding of informed consent or comply with&#xD;
             study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianwei Zhou, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhigang Zhang, M.D.</last_name>
    <phone>86+057189713631</phone>
    <email>zzg2011@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Second Affiliated hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianwei Zhou, M.D.</last_name>
      <phone>0571-89713634</phone>
      <email>jianwei-zhou@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Zhigang Zhang</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>CAR-T</keyword>
  <keyword>MESO</keyword>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Relapsed and Refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</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/NCT03799913
org study id: MESO
nct id: NCT03799913
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen
      receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
Primary Objectives

      1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with
      MESO-positive ovarian cancer.

      Secondary Objectives

        1. To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.

        2. To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
time frame: 1 years post infusion
measure: Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
time frame: 12 months post infusion
measure: Progress Free Survival (PFS) after administration
time frame: 12 months post infusion
measure: Duration of CAR-positive T cells in circulation
time frame: 12 months post infusion
measure: Detection of PD1 antibody in serum
time frame: 12 months post infusion
arm group label: anti-MESO CAR-T cells
arm group type: Experimental
description: Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients
intervention type: Biological
intervention name: anti-MESO CAR-T cells
description: Retroviral vector-transduced autologous T cells to express anti-MESO CARs
arm group label: anti-MESO CAR-T cells
intervention type: Drug
intervention name: Fludarabine
description: 30mg/m2/d
arm group label: anti-MESO CAR-T cells
intervention type: Drug
intervention name: Cyclophosphamide
description: 300mg/m2/d
arm group label: anti-MESO CAR-T cells
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianwei Zhou, M.D.
role: Study Chair
affiliation: Zhejiang University
last name: Zhigang Zhang, M.D.
phone: 86+057189713631
email: zzg2011@zju.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Zhigang Zhang
investigator title: Dr
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Cyclophosphamide
mesh term: Fludarabine
sharing ipd: No