<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/NCT02980315</url>
  </required_header>
  <id_info>
    <org_study_id>2016-ky-o43</org_study_id>
    <nct_id>NCT02980315</nct_id>
  </id_info>
  <brief_title>A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application</brief_title>
  <official_title>A New Efficient EBV AssociatedTechnologies of T Cells in Treating Malignant Tumors and Clinical Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Nanjing Medical University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of the designed LMP1-CAR -T cells and&#xD;
      determine whether the CAR-T cells are effective in the treatment of EBV associated malignant&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a&#xD;
      placebo.During the time of the treatment ,we will supervise the side effect of treated&#xD;
      group.At last we compare the survival rate and health condition of the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Nasopharyngeal Neoplasms</condition>
  <arm_group>
    <arm_group_label>CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the group treat with CAR-T cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the group treat with CAR-T cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAR-T cells</intervention_name>
    <description>the patients treat with CAR-T cells</description>
    <arm_group_label>CAR-T cells</arm_group_label>
    <other_name>adoptive immunotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of nasopharyngeal carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  •pregnant woman&#xD;
&#xD;
               -  severe autoimmune diseases&#xD;
&#xD;
               -  serious infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SecondNanjingMU</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen ren jie, doctor</last_name>
      <phone>008618951762675</phone>
      <phone_ext>13645151481</phone_ext>
      <email>renjiechenent@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nasopharyngeal carcinoma</keyword>
  <keyword>EBV related cancers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</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>
  <!-- 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/NCT02980315
org study id: 2016-ky-o43
nct id: NCT02980315
lead sponsor: 
The purpose of this study is to evaluate the safety of the designed LMP1-CAR -T cells and
      determine whether the CAR-T cells are effective in the treatment of EBV associated malignant
      tumors.
Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a
      placebo.During the time of the treatment ,we will supervise the side effect of treated
      group.At last we compare the survival rate and health condition of the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: all cause mortality
time frame: one year
arm group label: CAR-T cells
arm group type: Experimental
description: the group treat with CAR-T cells
arm group label: placebo
arm group type: No Intervention
description: the group treat with CAR-T cells
intervention type: Other
intervention name: CAR-T cells
description: the patients treat with CAR-T cells
arm group label: CAR-T cells
other name: adoptive immunotherapy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Nasopharyngeal Neoplasms
mesh term: Immunomodulating Agents