<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/NCT01694472</url>
  </required_header>
  <id_info>
    <org_study_id>CIH-RXB-201205002</org_study_id>
    <nct_id>NCT01694472</nct_id>
  </id_info>
  <brief_title>Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors</brief_title>
  <official_title>Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical safety and preliminary efficacy of&#xD;
      MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients,&#xD;
      such as malignant melanoma and lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <phase>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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>CR + PR = ORR</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Malignant Solid Tumors</condition>
  <arm_group>
    <arm_group_label>MAGE-A4 TCR Gene-Modified T Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MAGE-A4 TCR Gene-Modified T Cells</intervention_name>
    <description>The study consists of a 2-dose escalation scheme, and the patient receives twice in each dose. The starting dose is 1-3 x 10^9 cells of each TCR gene-modified cells and the second one is 3-8 x 10^9 cells of each TCR gene-modified cells. Two weeks after the first infusion the patient receives the same dose again, followed by infusions of IL-2 for 5 days. Thereafter, the patient receives peptide vaccinations on days 21 and 28.</description>
    <arm_group_label>MAGE-A4 TCR Gene-Modified T Cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sex: male or female&#xD;
&#xD;
          -  Age: from 18 to 80 years&#xD;
&#xD;
          -  Patients must have histologically confirmed solid tumors that have failed standard&#xD;
             therapies (surgery, chemotherapy, radiotherapy) and for which no curative options&#xD;
             exist, including, but not limited to:&#xD;
&#xD;
        Non-Small Cell Lung Carcinoma Malignant melanoma Esophageal carcinoma Head and neck&#xD;
        carcinoma&#xD;
&#xD;
          -  HLA-A*24:02&#xD;
&#xD;
          -  MAGE-A4 positive in the test by RT-PCR on tumor tissue or immunohistochemistry of&#xD;
             resected tissue of the patient.&#xD;
&#xD;
          -  PS ECOG 0 or &lt;2&#xD;
&#xD;
          -  Laboratory tests results 7 days before the start of treatment:&#xD;
&#xD;
        White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more&#xD;
        than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less&#xD;
        than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase:&#xD;
        less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25&#xD;
        × ULN&#xD;
&#xD;
          -  Pregnancy test: the test of women of child-bearing period must be negative 7 days&#xD;
             before the start of treatment&#xD;
&#xD;
          -  Contraception: male and female subjects of child-bearing period must adopt a reliable&#xD;
             method of contraception before entry into this study until 30 days after stopping this&#xD;
             study&#xD;
&#xD;
          -  Informed consent: subject must have the ability to understand and voluntarily sign a&#xD;
             written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with life-threatening condition or complication other than their basic&#xD;
             disease&#xD;
&#xD;
          -  Pregnant or lactation. Patients both males and female with reproductive potential&#xD;
             (i.e. menopausal for less than 1 year and not surgically sterilized) must practice&#xD;
             effective contraceptive measures throughout the study. Women of childbearing potential&#xD;
             must provide a negative pregnancy test (serum or urine) within 14 days prior to&#xD;
             registration&#xD;
&#xD;
          -  Active systemic infections&#xD;
&#xD;
          -  History of neoplasms: other neoplasms&#xD;
&#xD;
          -  Medical history: active CNS disease, or congestive heart failure, or severe coronary&#xD;
             artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy&#xD;
&#xD;
          -  Metastasis: clinical symptoms of brain metastasis&#xD;
&#xD;
          -  Other clinical trial: the subject received other clinical trial before this study&#xD;
&#xD;
          -  Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B&#xD;
             virus, or hepatitis C virus was positive&#xD;
&#xD;
          -  Compliance: poor compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>December 21, 2015</last_update_submitted>
  <last_update_submitted_qc>December 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</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>Neoplasms</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/NCT01694472
org study id: CIH-RXB-201205002
nct id: NCT01694472
lead sponsor: 
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of
      MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients,
      such as malignant melanoma and lung cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Objective response rate
time frame: Up to 12 months
description: CR + PR = ORR
arm group label: MAGE-A4 TCR Gene-Modified T Cells
arm group type: Experimental
intervention type: Biological
intervention name: MAGE-A4 TCR Gene-Modified T Cells
description: The study consists of a 2-dose escalation scheme, and the patient receives twice in each dose. The starting dose is 1-3 x 10^9 cells of each TCR gene-modified cells and the second one is 3-8 x 10^9 cells of each TCR gene-modified cells. Two weeks after the first infusion the patient receives the same dose again, followed by infusions of IL-2 for 5 days. Thereafter, the patient receives peptide vaccinations on days 21 and 28.
arm group label: MAGE-A4 TCR Gene-Modified T Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms