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/NCT05987527</url>
    </required_header>
    <id_info>
      <org_study_id>TX200-KT03</org_study_id>
      <secondary_id>2022-002440-40</secondary_id>
      <nct_id>NCT05987527</nct_id>
    </id_info>
    <brief_title>Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)</brief_title>
    <official_title>Long-Term Follow-Up of Patients Who Have Received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg Therapy, TX200-TR101) in a Prior Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sangamo Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sangamo Therapeutics</source>
    <oversight_info>
      <has_dmc>No</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 long-term follow-up study is being conducted to collect long-term (up to 15 years&#xD;
        post-infusion) safety and tolerability data from subjects enrolled in studies evaluating&#xD;
        TX200-TR101.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is long- term follow up observational trial for patients who participated previously to&#xD;
        a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of&#xD;
        autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched&#xD;
        living donor kidney transplant recipients, with a control cohort of mismatched kidney&#xD;
        transplant recipients of similar immunological risk.&#xD;
  &#xD;
        The aim is for this observational long-term follow up study (TX200-KT03) is to collect&#xD;
        long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled&#xD;
        in studies evaluating TX200-TR101. In addition, the long-term effects and durability of the&#xD;
        clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and&#xD;
        compared with control participants in the interventional Study (TX200- KT02).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 4, 2039</completion_date>
    <primary_completion_date type="Anticipated">September 4, 2039</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Long term graft related outcomes</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Incidence of graft rejection according to the Banff classification criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term safety outcomes to evaluate the effect of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Number of in-patient days in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term safety outcomes</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Incidence of Adverse Events related to TX20-TR101</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term safety follow up on the effect of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>incidence of Adverse Events of special interest as defined in the protocol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term safety evaluation of the effect of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Incidence of anti-drug antibodies against HLA A2 CAR Tregs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term safety</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Change in immunosuppression regime</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Composite efficacy profile of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Incidence of graft loss due to rejection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate Composite efficacy profile of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the Composite efficacy profile of TX200-TR101</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact on Quality of Life</measure>
      <time_frame>Up to 15 years post infusion</time_frame>
      <description>SF-36 Questionnaire scaled with lower score meaning more disability</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">21</enrollment>
    <condition>Kidney Transplant Rejection</condition>
    <condition>End Stage Renal Disease</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <description>Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation&#xD;
  Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Urine sample</intervention_name>
      <description>Routine procedures</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Routine procedures</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lifestyle questionnaire</intervention_name>
      <description>Lifestyle questionnaire</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Whole blood, and serum&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented&#xD;
          to participate in this LTFU study,&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted&#xD;
               kidney and have either completed or withdrawn from that study.&#xD;
  &#xD;
            2. Willing and able to provide written informed consent (IC) in accordance with local&#xD;
               regulations and governing Independent Ethics Committee (IEC)/Institutional Review&#xD;
               Board (IRB) requirements prior to any procedure or evaluation performed specifically&#xD;
               for the sole purpose of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>72 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Hospitals Leuven</name>
        <address>
          <city>Leuven</city>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Charité Universitätsmedizin</name>
        <address>
          <city>Berlin</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University Medical Center Groningen</name>
        <address>
          <city>Groningen</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Leiden University Medical Centre</name>
        <address>
          <city>Leiden</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Erasmus MC, University Medical Center</name>
        <address>
          <city>Rotterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Oxford University Hospitals NHS Foundation Trust</name>
        <address>
          <city>Oxford</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>Germany</country>
      <country>Netherlands</country>
      <country>United Kingdom</country>
    </location_countries>
    <link>
      <url>https://clinicaltrials.gov/ct2/show/NCT04817774?term=TX200-KT02&amp;draw=2&amp;rank=1</url>
      <description>Link to parent study STEADFAST, TX200-KT02</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Regulatory T-Cells</keyword>
    <keyword>Genetically modified cells</keyword>
    <keyword>Chimeric antigen receptor</keyword>
    <keyword>Long term follow up</keyword>
    <keyword>T-Regs</keyword>
    <keyword>Cell Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987527
  org study id: TX200-KT03
  secondary id: 2022-002440-40
  nct id: NCT05987527
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This long-term follow-up study is being conducted to collect long-term (up to 15 years
        post-infusion) safety and tolerability data from subjects enrolled in studies evaluating
        TX200-TR101.
  This is long- term follow up observational trial for patients who participated previously to
        a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of
        autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched
        living donor kidney transplant recipients, with a control cohort of mismatched kidney
        transplant recipients of similar immunological risk.
  
        The aim is for this observational long-term follow up study (TX200-KT03) is to collect
        long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled
        in studies evaluating TX200-TR101. In addition, the long-term effects and durability of the
        clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and
        compared with control participants in the interventional Study (TX200- KT02).
  observational model: Case-Control
  time perspective: Prospective
  measure: Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival
  time frame: Up to 15 years post infusion
  description: Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
  measure: Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
  time frame: Up to 15 years post infusion
  description: Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
  measure: Long term graft related outcomes
  time frame: Up to 15 years post infusion
  description: Incidence of graft rejection according to the Banff classification criteria
  measure: Long term safety outcomes to evaluate the effect of TX200-TR101
  time frame: Up to 15 years post infusion
  description: Number of in-patient days in hospital
  measure: Long term safety outcomes
  time frame: Up to 15 years post infusion
  description: Incidence of Adverse Events related to TX20-TR101
  measure: Long term safety follow up on the effect of TX200-TR101
  time frame: Up to 15 years post infusion
  description: incidence of Adverse Events of special interest as defined in the protocol
  measure: Long term safety evaluation of the effect of TX200-TR101
  time frame: Up to 15 years post infusion
  description: Incidence of anti-drug antibodies against HLA A2 CAR Tregs
  measure: Long term safety
  time frame: Up to 15 years post infusion
  description: Change in immunosuppression regime
  measure: Composite efficacy profile of TX200-TR101
  time frame: Up to 15 years post infusion
  description: Incidence of graft loss due to rejection
  measure: Evaluate Composite efficacy profile of TX200-TR101
  time frame: Up to 15 years post infusion
  description: Death
  measure: Evaluation of the Composite efficacy profile of TX200-TR101
  time frame: Up to 15 years post infusion
  description: Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate
  measure: Impact on Quality of Life
  time frame: Up to 15 years post infusion
  description: SF-36 Questionnaire scaled with lower score meaning more disability
  arm group label: Treatment group
  description: Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation
  Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02
  arm group label: Control group
  description: Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects
  intervention type: Diagnostic Test
  intervention name: Urine sample
  description: Routine procedures
  arm group label: Control group
  arm group label: Treatment group
  intervention type: Diagnostic Test
  intervention name: Blood sample
  description: Routine procedures
  arm group label: Control group
  arm group label: Treatment group
  intervention type: Other
  intervention name: Lifestyle questionnaire
  description: Lifestyle questionnaire
  arm group label: Control group
  arm group label: Treatment group
  Whole blood, and serum
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 72 Years
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Belgium
  country: Germany
  country: Netherlands
  country: United Kingdom
  url: https://clinicaltrials.gov/ct2/show/NCT04817774?term=TX200-KT02&draw=2&rank=1
  description: Link to parent study STEADFAST, TX200-KT02
  responsible party type: Sponsor
  mesh term: Kidney Failure, Chronic
  sharing ipd: No