<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/NCT03029338</url>
  </required_header>
  <id_info>
    <org_study_id>XH-CD19CART-002</org_study_id>
    <nct_id>NCT03029338</nct_id>
  </id_info>
  <brief_title>CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma</brief_title>
  <official_title>CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Juventas Cell Therapy Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Hematology &amp; Blood Diseases Hospital, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this single-center, open-label, no control, prospective clinical trial, a total of 10&#xD;
      relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be&#xD;
      enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to&#xD;
      patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The&#xD;
      purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells&#xD;
      in patients with relapsed or refractory CD19 positive B-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a&#xD;
      total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be&#xD;
      enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv&#xD;
      TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on&#xD;
      day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be&#xD;
      monitored. The purpose of current study is to determine the clinical efficacy and safety of&#xD;
      CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell&#xD;
      lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2017</start_date>
  <completion_date type="Actual">June 22, 2021</completion_date>
  <primary_completion_date type="Actual">May 22, 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>Number of patients with adverse events</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of the adverse events</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival(PFS)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistence of CAR T cells in vivo</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Lymphomas Non-Hodgkin's B-Cell</condition>
  <condition>Relapse</condition>
  <arm_group>
    <arm_group_label>CD19 CAR T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CD19 CAR T cells will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CD19 CAR T cells</intervention_name>
    <description>CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.</description>
    <arm_group_label>CD19 CAR T cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell&#xD;
             lymphoma.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.&#xD;
&#xD;
          -  Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of&#xD;
             normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5&#xD;
             x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured&#xD;
             or calculated creatinine clearance of ≥ 40ml/min.&#xD;
&#xD;
          -  Male and female of reproductive potential must agree to use birth control during the&#xD;
             study and for at least 6 weeks post study.&#xD;
&#xD;
          -  Patients should sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with central nervous system involvement by lymphoma.&#xD;
&#xD;
          -  Prior chemotherapy within 2 weeks before enrollment with the following exceptions:&#xD;
             steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine&#xD;
             are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.&#xD;
&#xD;
          -  Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before&#xD;
             enrollment. Patients must have completed immunosuppression therapy prior to&#xD;
             enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either&#xD;
             moderate or severe limited chronic GVHD, or extensive GVHD of any severity.&#xD;
&#xD;
          -  Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV&#xD;
             infection or severe inflammatory disease).&#xD;
&#xD;
          -  Major surgery within 4 weeks before enrollment.&#xD;
&#xD;
          -  Impaired cardiac function:Ejection fraction ≤45 % on MUGA scan. QTc interval &gt;&#xD;
             450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting&#xD;
             study; other clinically significant heart disease (e.g. unstable angina, congestive&#xD;
             heart failure or uncontrolled hypertension, uncontrolled arrhythmias).&#xD;
&#xD;
          -  Administration of live vaccine ≤ 4 weeks before enrollment.&#xD;
&#xD;
          -  Other concurrent severe and/or uncontrolled medical conditions: Patients with another&#xD;
             primary malignant disease, except those that do not currently require treatment; acute&#xD;
             or chronic liver, pancreatic or severe renal disease; another severe and/or&#xD;
             life-threatening medical disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dehui Zou, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
    <investigator_full_name>Zou Dehui</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>lymphoma</keyword>
  <keyword>non-hodgkin</keyword>
  <keyword>B-cell</keyword>
  <keyword>CD19 CAR T cells</keyword>
  <keyword>refractory</keyword>
  <keyword>relapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Recurrence</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/NCT03029338
org study id: XH-CD19CART-002
nct id: NCT03029338
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In this single-center, open-label, no control, prospective clinical trial, a total of 10
      relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be
      enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to
      patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The
      purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells
      in patients with relapsed or refractory CD19 positive B-cell lymphoma.
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a
      total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be
      enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv
      TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on
      day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be
      monitored. The purpose of current study is to determine the clinical efficacy and safety of
      CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell
      lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: 2 years
measure: Severity of the adverse events
time frame: 2 years
measure: Response rate
time frame: 12 months
measure: Progression-free survival(PFS)
time frame: 2 years
measure: Persistence of CAR T cells in vivo
time frame: 2 years
arm group label: CD19 CAR T cells
arm group type: Experimental
description: CD19 CAR T cells will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2.
intervention type: Biological
intervention name: CD19 CAR T cells
description: CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
arm group label: CD19 CAR T cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dehui Zou, Dr.
role: Principal Investigator
affiliation: Institute of Hematology & Blood Diseases Hospital, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
investigator full name: Zou Dehui
investigator title: Dr.
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Recurrence
sharing ipd: Undecided