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/NCT05993299</url>
    </required_header>
    <id_info>
      <org_study_id>208467 Substudy 1</org_study_id>
      <nct_id>NCT05993299</nct_id>
    </id_info>
    <brief_title>Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma</brief_title>
    <official_title>Evaluation of Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GlaxoSmithKline</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This trial will evaluate safety and efficacy of human engineered T-cell therapies, in&#xD;
        participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">December 31, 2019</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Actual">October 12, 2022</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>Up to approximately 36 months</time_frame>
      <description>Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants within the analysis population per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. as determined by the local investigators.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
      <description>Time to response is defined as time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by local investigators per RECIST v1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
      <description>Duration of response is defined as, in the subset of participants who show a confirmed CR or PR as assessed by local investigators, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
      <description>Disease control rate is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with minimal 12 weeks duration as determined by local investigators per RECIST v1.1 relative to the total number of participants within the analysis population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
      <description>Progression free survival is defined as the time from the date of T-cell administration until first documented sign of disease progression per RECIST v1.1, or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with adverse events (AEs), serious adverse events (SAEs) according to severity</measure>
      <time_frame>Up to approximately 53 months</time_frame>
      <description>AEs, SAEs and AESIs will be collected. Severity of AEs and SAEs will be summarized using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with AEs of special interest (AESI) according to severity</measure>
      <time_frame>Up to approximately 53 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with replication competent lentivirus (RCL)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with insertional oncogenesis (IO)</measure>
      <time_frame>Up to approximately 53 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum transgene expansion (Cmax) of letetresgene autoleucel</measure>
      <time_frame>Up to approximately 53 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Cmax (Tmax) of letetresgene autoleucel</measure>
      <time_frame>Up to approximately 53 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration time curve from zero to time 28 days (AUC[0-28]) of letetresgene autoleucel</measure>
      <time_frame>Up to 28 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">7</enrollment>
    <condition>Neoplasms</condition>
    <arm_group>
      <arm_group_label>Letetresgene autoleucel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Letetresgene autoleucel</intervention_name>
      <description>Letetresgene autoleucel will be administered.</description>
      <arm_group_label>Letetresgene autoleucel</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant must be greater than or equal to 10 years of age on the day of signing&#xD;
               informed consent.&#xD;
  &#xD;
            -  Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles&#xD;
               by a designated central laboratory&#xD;
  &#xD;
            -  Participant's tumor is positive for NY-ESO-1 expression by a designated central&#xD;
               laboratory.&#xD;
  &#xD;
            -  Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma&#xD;
               (MRCLS)&#xD;
  &#xD;
            -  Performance status: dependent on age - Lansky &gt; 60, Karnofsky &gt; 60, Eastern&#xD;
  &#xD;
            -  Cooperative Oncology Group 0-1.&#xD;
  &#xD;
            -  Participant must have adequate organ function and blood cell counts, within 7 days&#xD;
               prior to leukapheresis.&#xD;
  &#xD;
            -  At time of treatment, participant has measurable disease according to RECIST v1.1.&#xD;
  &#xD;
            -  Consultation for prior history per protocol specifications.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Central nervous system metastases.&#xD;
  &#xD;
            -  Any other prior malignancy that is not in complete remission.&#xD;
  &#xD;
            -  Clinically significant systemic illness.&#xD;
  &#xD;
            -  Prior or active demyelinating disease.&#xD;
  &#xD;
            -  History of chronic or recurrent (within the last year prior to leukapheresis) severe&#xD;
               autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring&#xD;
               steroids or other immunosuppressive treatments.&#xD;
  &#xD;
            -  Previous treatment with genetically engineered NY-ESO-1-specific T cells.&#xD;
  &#xD;
            -  Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.&#xD;
  &#xD;
            -  Prior gene therapy using an integrating vector.&#xD;
  &#xD;
            -  Previous allogeneic hematopoietic stem cell transplant.&#xD;
  &#xD;
            -  Washout periods for prior radiotherapy and systemic chemotherapy must be followed.&#xD;
  &#xD;
            -  Participant had major surgery in less than or equal to 28 days of first dose of study&#xD;
               intervention.&#xD;
  &#xD;
            -  Prior radiation exceeds protocol specified limits.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>GSK Clinical Trials</last_name>
      <role>Study Director</role>
      <affiliation>GlaxoSmithKline</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15232</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75390-9063</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Montreal</city>
          <state>Quebec</state>
          <zip>H1T 2M4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Amsterdam</city>
          <zip>1066 CX</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>London</city>
          <zip>SW3 6JJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
      <country>Netherlands</country>
      <country>United Kingdom</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adoptive T-cell therapy</keyword>
    <keyword>Letetresgene autoleucel</keyword>
    <keyword>Lete-cel</keyword>
    <keyword>GSK3377794</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liposarcoma</mesh_term>
      <mesh_term>Sarcoma, Synovial</mesh_term>
      <mesh_term>Liposarcoma, Myxoid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>http://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
    </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/NCT05993299
  org study id: 208467 Substudy 1
  nct id: NCT05993299
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This trial will evaluate safety and efficacy of human engineered T-cell therapies, in
        participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall response rate (ORR)
  time frame: Up to approximately 36 months
  description: Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants within the analysis population per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. as determined by the local investigators.
  measure: Time to response (TTR)
  time frame: Up to approximately 53 months
  description: Time to response is defined as time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by local investigators per RECIST v1.1.
  measure: Duration of response (DOR)
  time frame: Up to approximately 53 months
  description: Duration of response is defined as, in the subset of participants who show a confirmed CR or PR as assessed by local investigators, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.
  measure: Disease control rate (DCR)
  time frame: Up to approximately 53 months
  description: Disease control rate is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with minimal 12 weeks duration as determined by local investigators per RECIST v1.1 relative to the total number of participants within the analysis population.
  measure: Progression free survival (PFS)
  time frame: Up to approximately 53 months
  description: Progression free survival is defined as the time from the date of T-cell administration until first documented sign of disease progression per RECIST v1.1, or death.
  measure: Number of Participants with adverse events (AEs), serious adverse events (SAEs) according to severity
  time frame: Up to approximately 53 months
  description: AEs, SAEs and AESIs will be collected. Severity of AEs and SAEs will be summarized using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  measure: Number of Participants with AEs of special interest (AESI) according to severity
  time frame: Up to approximately 53 months
  measure: Number of participants with replication competent lentivirus (RCL)
  time frame: Up to approximately 53 months
  measure: Number of participants with insertional oncogenesis (IO)
  time frame: Up to approximately 53 months
  measure: Maximum transgene expansion (Cmax) of letetresgene autoleucel
  time frame: Up to approximately 53 months
  measure: Time to Cmax (Tmax) of letetresgene autoleucel
  time frame: Up to approximately 53 months
  measure: Area under the concentration time curve from zero to time 28 days (AUC[0-28]) of letetresgene autoleucel
  time frame: Up to 28 days
  arm group label: Letetresgene autoleucel
  arm group type: Experimental
  intervention type: Drug
  intervention name: Letetresgene autoleucel
  description: Letetresgene autoleucel will be administered.
  arm group label: Letetresgene autoleucel
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: N/A
  healthy volunteers: No
  last name: GSK Clinical Trials
  role: Study Director
  affiliation: GlaxoSmithKline
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Canada
  country: Netherlands
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: Liposarcoma
  mesh term: Sarcoma, Synovial
  mesh term: Liposarcoma, Myxoid
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
  ipd url: http://www.gsk.com/en-gb/innovation/trials/data-transparency/