<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/NCT03811457</url>
  </required_header>
  <id_info>
    <org_study_id>UCAR019</org_study_id>
    <nct_id>NCT03811457</nct_id>
  </id_info>
  <brief_title>Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma</brief_title>
  <official_title>Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UWELL Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Liaocheng People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UWELL Biopharma</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>
      B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of&#xD;
      non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic&#xD;
      leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation&#xD;
      therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite&#xD;
      these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a&#xD;
      CD19-directed genetically-modified autologous immunotherapy. This study is designed to&#xD;
      evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with&#xD;
      anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies,&#xD;
      including DLBCL and ALL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</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>The adverse events associated with CAR T cell product infusions are assessed.</measure>
    <time_frame>30 days</time_frame>
    <description>The type, frequency, severity, and duration of adverse events will be summarized</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Lymphoma Leukemia</condition>
  <arm_group>
    <arm_group_label>Welgenaleucel (UWC19)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Welgenaleucel</intervention_name>
    <description>Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.</description>
    <arm_group_label>Welgenaleucel (UWC19)</arm_group_label>
    <other_name>UWC19</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CD19+ leukemia or lymphoma patients with no available curative treatment options who&#xD;
             have limited prognosis with currently available therapies&#xD;
&#xD;
          -  Absolute lymphocyte count, ALC )≧600/μl&#xD;
&#xD;
          -  HIV, HTLV, Syphilis negative&#xD;
&#xD;
          -  GPT ≦200 U/L&#xD;
&#xD;
          -  Cr ≦221 umol/L&#xD;
&#xD;
          -  Adequate venous access for apheresis, and no other contraindications for&#xD;
             leukapheresis.&#xD;
&#xD;
          -  Voluntary informed consent is given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight &lt; 20Kg&#xD;
&#xD;
          -  Pregnant women.&#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 or cell therapy products.&#xD;
&#xD;
          -  Any uncontrolled active medical disorder that would preclude participation as&#xD;
             outlined.&#xD;
&#xD;
          -  Expected survival&lt; 12 weeks&#xD;
&#xD;
          -  Received investigational drug or device within 30 days pre-trial;&#xD;
&#xD;
          -  Patients with any other serious diseases considered by the investigator(s) not in the&#xD;
             condition to enter the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheng-Yi Kuo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UWELL Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liaocheng People Hospital</name>
      <address>
        <city>Liaocheng</city>
        <state>Shandong</state>
        <zip>252000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR-T cell, CD19, Lymphoma, Leukemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</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/NCT03811457
org study id: UCAR019
nct id: NCT03811457
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of
      non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic
      leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation
      therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite
      these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a
      CD19-directed genetically-modified autologous immunotherapy. This study is designed to
      evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with
      anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies,
      including DLBCL and ALL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The adverse events associated with CAR T cell product infusions are assessed.
time frame: 30 days
description: The type, frequency, severity, and duration of adverse events will be summarized
arm group label: Welgenaleucel (UWC19)
arm group type: Experimental
description: The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times
intervention type: Genetic
intervention name: Welgenaleucel
description: Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
arm group label: Welgenaleucel (UWC19)
other name: UWC19
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
last name: Cheng-Yi Kuo, PhD
role: Study Director
affiliation: UWELL Biopharma
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia