<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/NCT03265106</url>
  </required_header>
  <id_info>
    <org_study_id>2017FDEK-BinD19</org_study_id>
    <nct_id>NCT03265106</nct_id>
  </id_info>
  <brief_title>A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects</brief_title>
  <official_title>A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen BinDeBio Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shenzhen BinDeBio Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm, open-label, uni-center, phase I/II study to determine the safety and&#xD;
      efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell&#xD;
      acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic&#xD;
      SCT, or are otherwise ineligible for allogeneic stem cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2021</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>Number of Participants With Adverse Events [Safety and Feasibility]</measure>
    <time_frame>Study treatment until Week 24</time_frame>
    <description>To evaluate the safety and feasibility of BinD19 CAR-T cells in patients with refractory /relapsed B-cell acute lymphoblastic leukemia or lymphoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response [Efficacy]</measure>
    <time_frame>5 years</time_frame>
    <description>Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. Efficacy assessments for Lymphoma were based on tumor load, B cell number and immunoglobulins.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood</condition>
  <condition>Refractory B-cell Acute Lymphoblastic Leukemia, Childhood</condition>
  <condition>Relapsed/Refractory B-cell Lymphoma, Childhood</condition>
  <arm_group>
    <arm_group_label>BinD19</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/ maximum dose: 1x10^6/kg / 1x10^7/kg administered to childhood patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BinD19</intervention_name>
    <description>Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR- ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.</description>
    <arm_group_label>BinD19</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with CD19+ B cell malignancies in patients with no available&#xD;
             curative treatment options (such as autologous or allogeneic SCT) who have limited&#xD;
             prognosis (several months to &lt; 2 year survival) with currently available therapies&#xD;
             will be enrolled.&#xD;
&#xD;
          -  CD19+ leukemia or lymphoma&#xD;
&#xD;
          -  Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available&#xD;
             family member or unrelated donor&#xD;
&#xD;
          -  Follicular lymphoma, previously identified as CD19+:&#xD;
&#xD;
          -  Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)&#xD;
&#xD;
          -  ECOG result is 0, 1 or 2.&#xD;
&#xD;
          -  With normal heart, liver and kidney functions.&#xD;
&#xD;
          -  Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody&#xD;
             for HCV, HIV and syphilis.&#xD;
&#xD;
          -  Negative in pregnancy test (female subject only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECOG result is 3, 4 or 5.&#xD;
&#xD;
          -  Pregnant or lactating female&#xD;
&#xD;
          -  Uncontrolled active infection&#xD;
&#xD;
          -  Active hepatitis B or hepatitis C infection&#xD;
&#xD;
          -  Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not&#xD;
             exclusionary&#xD;
&#xD;
          -  Previously treatment with any gene therapy products&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Enrolled to other clinical study in the last 4 weeks.&#xD;
&#xD;
          -  Subjects with systemic auto-immune disease or immunodeficiency.&#xD;
&#xD;
          -  Subjects with CNS diseases.&#xD;
&#xD;
          -  Subjects with secondary tumors.&#xD;
&#xD;
          -  Subjects with tumor infiltration in liver, brain or GI tract.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ZHONG HUA YANG</last_name>
    <role>Study Director</role>
    <affiliation>Shenzhen BinDeBio Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</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>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03265106
org study id: 2017FDEK-BinD19
nct id: NCT03265106
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and
      efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell
      acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic
      SCT, or are otherwise ineligible for allogeneic stem cell transplant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Adverse Events [Safety and Feasibility]
time frame: Study treatment until Week 24
description: To evaluate the safety and feasibility of BinD19 CAR-T cells in patients with refractory /relapsed B-cell acute lymphoblastic leukemia or lymphoma.
measure: Overall Response [Efficacy]
time frame: 5 years
description: Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. Efficacy assessments for Lymphoma were based on tumor load, B cell number and immunoglobulins.
arm group label: BinD19
arm group type: Experimental
description: BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/ maximum dose: 1x10^6/kg / 1x10^7/kg administered to childhood patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.
intervention type: Biological
intervention name: BinD19
description: Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR- ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
arm group label: BinD19
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: ZHONG HUA YANG
role: Study Director
affiliation: Shenzhen BinDeBio Ltd.
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: No