xml: <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/NCT06019507</url>
    </required_header>
    <id_info>
      <org_study_id>TCD601G201</org_study_id>
      <nct_id>NCT06019507</nct_id>
    </id_info>
    <brief_title>A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation</brief_title>
    <official_title>A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ITB-Med LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ITB-Med LLC</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>
        The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can&#xD;
        induce allogeneic tolerance in liver transplant recipients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 29, 2022</start_date>
    <completion_date type="Anticipated">June 2029</completion_date>
    <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
    <phase>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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients</measure>
      <time_frame>30 months</time_frame>
      <description>The number of transplant recipients patients off of immunosuppression therapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To explore the safety of TCD601</measure>
      <time_frame>30 months</time_frame>
      <description>The number of adverse events and serious adverse events</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Liver Transplantation</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>TCD601</intervention_name>
      <description>Investigational Product</description>
      <arm_group_label>Arm 1</arm_group_label>
      <other_name>siplizumab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Cyclophosphamide</intervention_name>
      <description>Conditioning Regimen</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TAC</intervention_name>
      <description>Immunosuppression Therapy</description>
      <arm_group_label>Arm 1</arm_group_label>
      <other_name>Tacrolimus</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MMF</intervention_name>
      <description>Immunosuppression Therapy</description>
      <arm_group_label>Arm 1</arm_group_label>
      <other_name>Mycophenolate Mofetil</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Corticosteroids</intervention_name>
      <description>Immunosuppression Therapy</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to understand the study requirements and provide written informed consent before&#xD;
               and study assessment is performed&#xD;
  &#xD;
            -  Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant&#xD;
  &#xD;
            -  Male study subjects willing to maintain barrier contraception (condom) and agree not&#xD;
               to father a child until 12 weeks after the last dose of MMF&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or nursing (lactating) women&#xD;
  &#xD;
            -  Subjects with a history of TB or latent TB infection&#xD;
  &#xD;
            -  Subjects with a history of cancer&#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>Kellie Kennon, BSN</last_name>
      <role>Study Director</role>
      <affiliation>ITB-MED</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jesse Scott, MPH</last_name>
      <phone>212-969-7821</phone>
      <email>jesse.scott@itb-med.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karolinska University Hospital</name>
        <address>
          <city>Stockholm</city>
          <state>Huddinge</state>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karin Fransson</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>October 2022</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mycophenolic Acid</mesh_term>
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Tacrolimus</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019507
  org study id: TCD601G201
  nct id: NCT06019507
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can
        induce allogeneic tolerance in liver transplant recipients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients
  time frame: 30 months
  description: The number of transplant recipients patients off of immunosuppression therapy
  measure: To explore the safety of TCD601
  time frame: 30 months
  description: The number of adverse events and serious adverse events
  arm group label: Arm 1
  arm group type: Experimental
  description: TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
  intervention type: Biological
  intervention name: TCD601
  description: Investigational Product
  arm group label: Arm 1
  other name: siplizumab
  intervention type: Biological
  intervention name: Cyclophosphamide
  description: Conditioning Regimen
  arm group label: Arm 1
  intervention type: Drug
  intervention name: TAC
  description: Immunosuppression Therapy
  arm group label: Arm 1
  other name: Tacrolimus
  intervention type: Drug
  intervention name: MMF
  description: Immunosuppression Therapy
  arm group label: Arm 1
  other name: Mycophenolate Mofetil
  intervention type: Drug
  intervention name: Corticosteroids
  description: Immunosuppression Therapy
  arm group label: Arm 1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Kellie Kennon, BSN
  role: Study Director
  affiliation: ITB-MED
  last name: Jesse Scott, MPH
  phone: 212-969-7821
  email: jesse.scott@itb-med.com
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Mycophenolic Acid
  mesh term: Cyclophosphamide
  mesh term: Tacrolimus