<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/NCT02259556</url>
  </required_header>
  <id_info>
    <org_study_id>CHN-PLAGH-BT-011</org_study_id>
    <nct_id>NCT02259556</nct_id>
  </id_info>
  <brief_title>CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas</brief_title>
  <acronym>CART30</acronym>
  <official_title>CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of&#xD;
      tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be&#xD;
      treated by CD30-specific CART cells (CART30).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When patients enroll on this trial, autologous CART-33 cells were generated from the&#xD;
      mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of&#xD;
      cell preparation of CART30, patients will receive a conditioning regimen including&#xD;
      cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient&#xD;
      will be given infusions of CART30 cells into the vein in escalating doses over a period of 3&#xD;
      to 5 consecutive days.&#xD;
&#xD;
      Extra blood will be drawn to measure the persistence of CART30 in vivo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2029</completion_date>
  <primary_completion_date type="Anticipated">October 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>Occurrence of related adverse events</measure>
    <time_frame>untill week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor response to CART30 cell infusions</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Evaluated mainly by computed tomography scanning</description>
  </secondary_outcome>
  <other_outcome>
    <measure>in vivo existence of CART30</measure>
    <time_frame>1 year</time_frame>
    <description>Measure mainly by the changes of CAR molecule levels in blood</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hodgkin's Lymphoma</condition>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>anti-CD30 CAR T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive CART30 cell infusions with an escalation dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CART30</intervention_name>
    <description>Cells will be infused 1 day after the completion of conditioning regimen.</description>
    <arm_group_label>anti-CD30 CAR T cells</arm_group_label>
    <other_name>anti-CD30 CAR T cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma&#xD;
             relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2&#xD;
             multidrug regimens and/or anti-CD30 antibody treatment.&#xD;
&#xD;
          -  Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are&#xD;
             unable to receive or complete standard chemotherapy.&#xD;
&#xD;
          -  Karnofsky or Lansky score greater than 60%.&#xD;
&#xD;
          -  Expected survival&gt;12 weeks.&#xD;
&#xD;
          -  Creatinine&lt;2.5mg/dl.&#xD;
&#xD;
          -  ALT (alanine aminotransferase)/AST (aspartate aminotransferase)&lt;3 fold normal.&#xD;
&#xD;
          -  Bilirubin&lt;2.5mg/dl.&#xD;
&#xD;
          -  Pulse oximetry of &gt;90% on room air.&#xD;
&#xD;
          -  Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of&#xD;
             expected corrected for hemoglobin.&#xD;
&#xD;
          -  Available autologous T cells with 10% or more expression of CD30 CAR determined by&#xD;
             flow-cytometry.&#xD;
&#xD;
          -  Patients or legal guardians must sign an informed consent indicating that they are&#xD;
             aware this is a research study and have been told of its possible benefits and toxic&#xD;
             side effects. Patients or their guardians will be given a copy of the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection such as hepatitis B or C.&#xD;
&#xD;
          -  Receive anti-CD30 antibody-based therapy within recent 6 weeks.&#xD;
&#xD;
          -  Current use of systemic corticosteroids.&#xD;
&#xD;
          -  Pregnant or lactating.&#xD;
&#xD;
          -  Confirmed tumor in pulmonary and archenteric tissues.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weidong Han, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weidong Han, Ph.D</last_name>
    <phone>86-10-66937463</phone>
    <email>hanwdrsw@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Quanshun Wang, Ph.D</last_name>
    <phone>86-10-66939486</phone>
    <email>wqs63@sohu.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weidong Han, Ph.D</last_name>
      <phone>86-10-66937463</phone>
      <email>hanwdrsw@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Quanshun Wang, Ph.D</last_name>
      <phone>86-10-66939486</phone>
      <email>wqs63@sohu.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>January 26, 2016</last_update_submitted>
  <last_update_submitted_qc>January 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Han weidong</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_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/NCT02259556
org study id: CHN-PLAGH-BT-011
nct id: NCT02259556
lead sponsor: 
has dmc: Yes
Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of
      tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be
      treated by CD30-specific CART cells (CART30).
When patients enroll on this trial, autologous CART-33 cells were generated from the
      mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of
      cell preparation of CART30, patients will receive a conditioning regimen including
      cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient
      will be given infusions of CART30 cells into the vein in escalating doses over a period of 3
      to 5 consecutive days.

      Extra blood will be drawn to measure the persistence of CART30 in vivo.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of related adverse events
time frame: untill week 24
measure: Anti-tumor response to CART30 cell infusions
time frame: Up to 24 weeks
description: Evaluated mainly by computed tomography scanning
measure: in vivo existence of CART30
time frame: 1 year
description: Measure mainly by the changes of CAR molecule levels in blood
arm group label: anti-CD30 CAR T cells
arm group type: Experimental
description: Patients receive CART30 cell infusions with an escalation dose.
intervention type: Biological
intervention name: CART30
description: Cells will be infused 1 day after the completion of conditioning regimen.
arm group label: anti-CD30 CAR T cells
other name: anti-CD30 CAR T cells
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Weidong Han, Ph.D
role: Study Chair
affiliation: Chinese PLA General Hospital
last name: Weidong Han, Ph.D
phone: 86-10-66937463
email: hanwdrsw@sina.com
last name: Quanshun Wang, Ph.D
phone: 86-10-66939486
email: wqs63@sohu.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Han weidong
investigator title: Director
mesh term: Lymphoma