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/NCT05981131</url>
    </required_header>
    <id_info>
      <org_study_id>QUILT-205</org_study_id>
      <nct_id>NCT05981131</nct_id>
    </id_info>
    <brief_title>Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)</brief_title>
    <official_title>QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ImmunityBio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ImmunityBio, Inc.</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>
        The purpose of this clinical trial is to obtain long-term follow-up information and status of&#xD;
        bladder cancer for patients who received study treatment in the QUILT-2.005 study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All 9 subjects that completed QUILT-2.005 phase 1b are planned to be enrolled in this study.&#xD;
  &#xD;
        Thus, the maximum enrollment for this study is 9 subjects. All enrolled subjects will be&#xD;
        followed every 12 months for life, or until withdrawal of consent, or if the Sponsor closes&#xD;
        the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2033</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2033</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Obtain Long Term Follow-Up data to be summarized using descriptive statistics</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>Follow-up data on survival status, bladder cancer status (high-grade or low-grade), cystoscopy results (including number of cystoscopies done for each subject), biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments (if available) related to bladder cancer will be collected from subjects who were enrolled and treated in QUILT-2.005 phase 1b study with intravesical N-803 plus BCG.&#xD;
  Study endpoints will be summarized with descriptive statistics. Continuous variables will be summarized as mean, median, standard deviation, and minimum and maximum values. Categorical variables will be summarized as the number and percentage of subjects in each category. All confidence intervals will be constructed at the two-sided 95% level of confidence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assess the Complete response yearly</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>CR rate yearly following completion of QUILT-2.005 phase 1b for subjects with CIS disease with or without papillary disease at the initial diagnosis.&#xD;
  CR rate (as determined by the Investigator) yearly following completion of QUILT-2.005 phase 1b will be reported along with a two-sided exact 95% confidence interval. The exact confidence interval will be calculated using the Clopper-Pearson method.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Asses Disease-free Survival</measure>
      <time_frame>assessed up to 60 months</time_frame>
      <description>To assess disease-free survival (DFS) since the first instillation of BCG plus N-803 in QUILT-2.005 phase 1b for subjects with papillary disease only at the initial diagnosis.&#xD;
  DFS (as determined by the Investigator) will be analyzed using Kaplan-Meier (KM) analysis methods. Subjects that are disease-free at the end of follow-up with censored at the last disease-free assessment</description>
    </primary_outcome>
    <enrollment type="Anticipated">9</enrollment>
    <condition>Non Muscle Invasive Bladder Cancer</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N803 plus Bacillus Calmette-Guerin (BCG)</intervention_name>
      <description>QUILT-2.005 phase 1b (NCT02138734) was an open-label, dose-escalation, multicenter study of intravesical Bacillus Calmette-Guerin (BCG) plus N-803 in BCG-naïve non muscle invasive bladder cancer (NMIBC). A modified 3 + 3 design was used. Three subjects were enrolled at each dose level starting at 100 μg/instillation of N-803 and subsequently increasing to 200 μg/instillation and 400 μg/instillation. A standard dose of BCG, 50 mg, was employed. The primary endpoints of the study were: determination of the maximum tolerated dose (MTD) and designation of the recommended dose (RD) of N-803 in combination with BCG in subjects who have BCG-naïve NMIBC; safety profile of N-803 plus BCG in treated subjects; and disease response rate in treated subjects. A total of 9 subjects with high-risk, high-grade, BCG-naïve, NMIBC were enrolled into 3 cohorts and treated by intravesical administration of N-803 plus BCG.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who were enrolled and completed treatment with intravesical N-803 plus BCG in&#xD;
          QUILT-2.005 phase 1b.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of&#xD;
               QUILT-2.005.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not applicable&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bobby Reddy, MD</last_name>
      <role>Study Director</role>
      <affiliation>ImmunityBio, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natalie Fernandez</last_name>
      <phone>7862618816</phone>
      <email>natalie.fernandez@immunitybio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Island Urology</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96813</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Denise Cullen, MD</last_name>
        <phone>808-536-2306</phone>
        <email>dcullen.iuo@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Jonah Soria</last_name>
        <phone>808-536-2306</phone>
        <email>jonahs1329@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Sergei Tikhonenkov, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 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 28, 2023</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>Urinary Bladder Neoplasms</mesh_term>
      <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>BCG Vaccine</mesh_term>
    </intervention_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/NCT05981131
  org study id: QUILT-205
  nct id: NCT05981131
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this clinical trial is to obtain long-term follow-up information and status of
        bladder cancer for patients who received study treatment in the QUILT-2.005 study.
  All 9 subjects that completed QUILT-2.005 phase 1b are planned to be enrolled in this study.
  
        Thus, the maximum enrollment for this study is 9 subjects. All enrolled subjects will be
        followed every 12 months for life, or until withdrawal of consent, or if the Sponsor closes
        the study.
  observational model: Other
  time perspective: Other
  measure: Obtain Long Term Follow-Up data to be summarized using descriptive statistics
  time frame: assessed up to 60 months
  description: Follow-up data on survival status, bladder cancer status (high-grade or low-grade), cystoscopy results (including number of cystoscopies done for each subject), biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments (if available) related to bladder cancer will be collected from subjects who were enrolled and treated in QUILT-2.005 phase 1b study with intravesical N-803 plus BCG.
  Study endpoints will be summarized with descriptive statistics. Continuous variables will be summarized as mean, median, standard deviation, and minimum and maximum values. Categorical variables will be summarized as the number and percentage of subjects in each category. All confidence intervals will be constructed at the two-sided 95% level of confidence.
  measure: Assess the Complete response yearly
  time frame: assessed up to 60 months
  description: CR rate yearly following completion of QUILT-2.005 phase 1b for subjects with CIS disease with or without papillary disease at the initial diagnosis.
  CR rate (as determined by the Investigator) yearly following completion of QUILT-2.005 phase 1b will be reported along with a two-sided exact 95% confidence interval. The exact confidence interval will be calculated using the Clopper-Pearson method.
  measure: Asses Disease-free Survival
  time frame: assessed up to 60 months
  description: To assess disease-free survival (DFS) since the first instillation of BCG plus N-803 in QUILT-2.005 phase 1b for subjects with papillary disease only at the initial diagnosis.
  DFS (as determined by the Investigator) will be analyzed using Kaplan-Meier (KM) analysis methods. Subjects that are disease-free at the end of follow-up with censored at the last disease-free assessment
  intervention type: Drug
  intervention name: N803 plus Bacillus Calmette-Guerin (BCG)
  description: QUILT-2.005 phase 1b (NCT02138734) was an open-label, dose-escalation, multicenter study of intravesical Bacillus Calmette-Guerin (BCG) plus N-803 in BCG-naïve non muscle invasive bladder cancer (NMIBC). A modified 3 + 3 design was used. Three subjects were enrolled at each dose level starting at 100 μg/instillation of N-803 and subsequently increasing to 200 μg/instillation and 400 μg/instillation. A standard dose of BCG, 50 mg, was employed. The primary endpoints of the study were: determination of the maximum tolerated dose (MTD) and designation of the recommended dose (RD) of N-803 in combination with BCG in subjects who have BCG-naïve NMIBC; safety profile of N-803 plus BCG in treated subjects; and disease response rate in treated subjects. A total of 9 subjects with high-risk, high-grade, BCG-naïve, NMIBC were enrolled into 3 cohorts and treated by intravesical administration of N-803 plus BCG.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Bobby Reddy, MD
  role: Study Director
  affiliation: ImmunityBio, Inc.
  last name: Natalie Fernandez
  phone: 7862618816
  email: natalie.fernandez@immunitybio.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  mesh term: Non-Muscle Invasive Bladder Neoplasms
  mesh term: BCG Vaccine
  sharing ipd: No