<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/NCT02968472</url>
  </required_header>
  <id_info>
    <org_study_id>LXUN</org_study_id>
    <nct_id>NCT02968472</nct_id>
  </id_info>
  <brief_title>A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia</brief_title>
  <official_title>Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First People's Hospital of Yunnan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenzhen Geno-Immune Medical Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First People's Hospital of Yunnan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19&#xD;
      (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells&#xD;
      tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change&#xD;
      process of the CART and residual tumor status of the patient are observe dynamically， which&#xD;
      summarizes the best therapeutic effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>B Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>prophylactic 4SCAR19 cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>prophylactic 4SCAR19 cells</intervention_name>
    <description>Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19</description>
    <arm_group_label>prophylactic 4SCAR19 cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged more than 6 months.&#xD;
&#xD;
          -  the immune phenotype analysis of patients with malignant B cell surface expression&#xD;
             CD19 molecules.&#xD;
&#xD;
          -  the Karnofsky performance status score over 80 points, is expected to patients&#xD;
             survival time is more than 3 months.&#xD;
&#xD;
          -  the important viscera function meet: heart ultrasound tip heart ejection fraction 50%&#xD;
             or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen&#xD;
             saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate&#xD;
             aminotransferase and aspartate aminotransferase3 times normal range or less, total&#xD;
             bilirubin of 2.0 mg/dl or less.&#xD;
&#xD;
          -  or greater Hgb 80 g/L.&#xD;
&#xD;
          -  no contraindications to solid and cell separation&#xD;
&#xD;
          -  the patient and family to have a strong willingness to participate in clinical trials,&#xD;
             and are willing to bear all the consequence caused by the test failed, and sign the&#xD;
             informed consent.&#xD;
&#xD;
          -  the panel discussion, combined with patient general condition, think the benefit is&#xD;
             greater than the risks involved in the clinical trials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  accompanied with other active disease, the treatment is difficult to correct.&#xD;
&#xD;
          -  bacteria, fungus, or virus infection, unable to control.&#xD;
&#xD;
          -  people living with HIV.&#xD;
&#xD;
          -  active hepatitis B virus and hepatitis C virus infection.&#xD;
&#xD;
          -  of pregnancy and nursing mothers.&#xD;
&#xD;
          -  before entering the test of the use of glucocorticoid systemic treatment within a&#xD;
             week.&#xD;
&#xD;
          -  confirmed before used CAR - but invalid patients treated T cells, after in the&#xD;
             physical examination, experts discuss confirmed by a team doesn't fit in the CAR again&#xD;
             - T treatment.Before used gene therapy method.&#xD;
&#xD;
          -  the researchers believe that might increase risk subjects or interfere with the test&#xD;
             results of any situation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huang Jianzhang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Shenzhen immune gene therapy research institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lai Xun, Doctor</last_name>
    <phone>13577096609</phone>
    <email>1729112214@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chang Lung-Ji, Doctor</last_name>
    <phone>13671121909</phone>
    <email>longflorida@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First people's hospital of Yunnan province</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>NCT650000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First People's Hospital of Yunnan</investigator_affiliation>
    <investigator_full_name>Xun Lai</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <keyword>4s CAR-T19</keyword>
  <keyword>B cell leukemia</keyword>
  <keyword>B-ALL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, B-Cell</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02968472
org study id: LXUN
nct id: NCT02968472
lead sponsor: 
collaborator: 
has dmc: Yes
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19
      (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells
      tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change
      process of the CART and residual tumor status of the patient are observe dynamically， which
      summarizes the best therapeutic effect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
time frame: 24 weeks
description: Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
measure: Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)
time frame: 1 year
arm group label: prophylactic 4SCAR19 cells
arm group type: Experimental
description: Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
intervention type: Genetic
intervention name: prophylactic 4SCAR19 cells
description: Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
arm group label: prophylactic 4SCAR19 cells
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Huang Jianzhang, Doctor
role: Study Chair
affiliation: Shenzhen immune gene therapy research institute
last name: Lai Xun, Doctor
phone: 13577096609
email: 1729112214@qq.com
last name: Chang Lung-Ji, Doctor
phone: 13671121909
email: longflorida@gmail.com
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: The First People's Hospital of Yunnan
investigator full name: Xun Lai
investigator title: chief physician
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, B-Cell
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
sharing ipd: Undecided