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/NCT06040918</url>
    </required_header>
    <id_info>
      <org_study_id>QUILT - 105</org_study_id>
      <nct_id>NCT06040918</nct_id>
    </id_info>
    <brief_title>Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis</brief_title>
    <official_title>Single Center Study Evaluating The Effects Of N-803 Stimulation On The Expansion, Enrichment, And Proliferation Of Natural Killer Cells Collected By Apheresis</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>No</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 is phase 1 single cohort study evaluating the effects of N-803 administration on&#xD;
        mononuclear cells (MNC) collected from healthy donors undergoing a procedure called&#xD;
        apheresis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This phase 1, single cohort study will enroll up to 10 healthy subjects. All subjects will be&#xD;
        pre-screened for eligibility. If the subject meets eligibility for study participation,&#xD;
        informed consent will be obtained. Screening will include a history and physical, review of&#xD;
        concomitant medications, assessment of NYHA functional status, assessment of ECOG performance&#xD;
        status, clinical laboratory tests, pregnancy test (for women of child-bearing abilities),&#xD;
        assessment of peripheral venous access, and a donor history questionnaire (DHQ). If subjects&#xD;
        meet eligibility criteria, they will be asked to undergo two apheresis collections and donate&#xD;
        their mononuclear cells (MNCs) for research purposes.&#xD;
  &#xD;
        Subjects will be scheduled for the first apheresis collection on study Day 1. Two total blood&#xD;
        volume (TBV) will be processed during each apheresis collections, which is currently the&#xD;
        collection centers standard practice. All subjects will receive N-803 at a fixed dose of 1 mg&#xD;
        by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The&#xD;
        N-803 dose may be administered starting on study Day 8 but no later than study Day 24. The&#xD;
        study day for N-803 administration will be determined based on the planned date of the second&#xD;
        apheresis collection. The second apheresis collection should occur between study Day 12 and&#xD;
        study Day 29. Two TBV will be processed during this collection.&#xD;
  &#xD;
        Subjects will be followed for collection of adverse events (AEs) from study Day 1 (first&#xD;
        apheresis collection) through the end of study (EOS) visit. Subjects will be instructed to&#xD;
        contact the study team in the event they experience AEs post N-803 administration (e.g.,&#xD;
        injection site reaction). In addition, AEs will be elicited from subjects during follow-up&#xD;
        phone calls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>Up to 10 healthy subjects</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA</measure>
      <time_frame>Study Day 1 through End of Study, assessed up to 45 days</time_frame>
      <description>Incidence of SAEs and overall AEs coded in MedDRA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious adverse events (SAEs) and overall adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)</measure>
      <time_frame>Study Day 1 through End of Study, assessed up to 45 days</time_frame>
      <description>Incidence of SAEs and overall AEs graded using the NCI CTCAE v5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Percentage of NK cells</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Percentage of NK cells as measured by flow cytometry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Immune profile</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Function and cell receptor profile of NK cells as measured by intracellular staining for cytokines, surface marker staining and assessments of cytotoxicity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Serum cytokines</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Serum Cytokines</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Evaluate + compare the ex vivo expansion + enrichment of NK cells collected by apheresis without N-803 (unstimulated) + with N-803 administration (stimulated) via frequency, number, and phenotype of immune cells measured by flow + mass cytometry.</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Frequency, number, and phenotype of immune cells as measured by flow and mass cytometry.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated) via Number of days to manufacture CENK and M-CENK.</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Number of days to manufacture CENK and M-CENK.</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated via Quality of CENK and M-CENK cells manufactured.</measure>
      <time_frame>Study Day 1 through Study Day 24, assessed up to 24 days</time_frame>
      <description>- Quality of CENK and M-CENK cells manufactured measured by the percentage of CD56 adequate for infusion.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>Healthy Subjects</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will be scheduled for first apheresis collection on study Day 1. All subjects will receive N-803 at a fixed dose of 1 mg by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N-803</intervention_name>
      <description>fixed dose of 1 mg by subcutaneous (SC) injection</description>
      <arm_group_label>Healthy Subjects</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old.&#xD;
  &#xD;
            -  Healthy donors must be free of acute or chronic medical conditions (e.g.,&#xD;
               hypertension, kidney disease, diabetes, autoimmune disease, cardiovascular disease).&#xD;
  &#xD;
            -  Able to understand and provide a signed informed consent that fulfills the relevant&#xD;
               Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.&#xD;
  &#xD;
            -  Adequate organ function, evidenced by the following laboratory results:&#xD;
  &#xD;
          Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Platelet count ≥ 100,000 cells/mm3&#xD;
          Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN); unless the&#xD;
          subject has documented Gilbert's syndrome Alanine aminotransferase (ALT)/aspartate&#xD;
          aminotransferase (AST) ≤ 3 x ULN Serum creatinine ≤ 2.0 mg/dL or 177 μmol/L&#xD;
  &#xD;
            -  Adequate peripheral venous access.&#xD;
  &#xD;
            -  Must be able to be in the clinic for up to 6 hours on the day of collection.&#xD;
  &#xD;
            -  Must be able to sit or recline with limited movement for approximately 2-3 hours.&#xD;
  &#xD;
            -  Must agree to provide blood samples for clinical testing and immunological analysis.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received systemic antibiotics within 14 days prior to apheresis collection.&#xD;
  &#xD;
            -  New York Heart Association (NYHA) functional assessment score of &gt; Class I.&#xD;
  &#xD;
            -  Any medical diagnosis that would prevent the donation of WBCs.&#xD;
  &#xD;
            -  History of or active human immunodeficiency virus (HIV).&#xD;
  &#xD;
            -  Active hepatitis B or hepatitis C.&#xD;
  &#xD;
            -  Have been advised by a medical provider not to donate blood.&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding. A negative serum pregnancy test in women of&#xD;
               child-bearing potential is required at screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leonard Sender, MD</last_name>
      <role>Study Director</role>
      <affiliation>ImmunityBio, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren Wilkins</last_name>
      <phone>310-882-9593</phone>
      <email>lauren.wilkins@immunitybio.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jayson Garmizo</last_name>
      <phone>310-912-2230</phone>
      <email>jayson.garmizo@immunitybio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Chan Soon-Shiong Institute for Medicine</name>
        <address>
          <city>El Segundo</city>
          <state>California</state>
          <zip>90245</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacqui Parnin</last_name>
        <phone>213-266-5604</phone>
        <email>Jacqueline.Parnin@cssifm.org</email>
      </contact>
      <contact_backup>
        <last_name>Jaya (Mini) Gill</last_name>
        <phone>213-266-5639</phone>
        <email>Jaya.Gill@cssifm.org</email>
      </contact_backup>
      <investigator>
        <last_name>Tara Seery, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 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>
    <!-- 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/NCT06040918
  org study id: QUILT - 105
  nct id: NCT06040918
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is phase 1 single cohort study evaluating the effects of N-803 administration on
        mononuclear cells (MNC) collected from healthy donors undergoing a procedure called
        apheresis.
  This phase 1, single cohort study will enroll up to 10 healthy subjects. All subjects will be
        pre-screened for eligibility. If the subject meets eligibility for study participation,
        informed consent will be obtained. Screening will include a history and physical, review of
        concomitant medications, assessment of NYHA functional status, assessment of ECOG performance
        status, clinical laboratory tests, pregnancy test (for women of child-bearing abilities),
        assessment of peripheral venous access, and a donor history questionnaire (DHQ). If subjects
        meet eligibility criteria, they will be asked to undergo two apheresis collections and donate
        their mononuclear cells (MNCs) for research purposes.
  
        Subjects will be scheduled for the first apheresis collection on study Day 1. Two total blood
        volume (TBV) will be processed during each apheresis collections, which is currently the
        collection centers standard practice. All subjects will receive N-803 at a fixed dose of 1 mg
        by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The
        N-803 dose may be administered starting on study Day 8 but no later than study Day 24. The
        study day for N-803 administration will be determined based on the planned date of the second
        apheresis collection. The second apheresis collection should occur between study Day 12 and
        study Day 29. Two TBV will be processed during this collection.
  
        Subjects will be followed for collection of adverse events (AEs) from study Day 1 (first
        apheresis collection) through the end of study (EOS) visit. Subjects will be instructed to
        contact the study team in the event they experience AEs post N-803 administration (e.g.,
        injection site reaction). In addition, AEs will be elicited from subjects during follow-up
        phone calls.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Up to 10 healthy subjects
  primary purpose: Other
  masking: None (Open Label)
  measure: Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA
  time frame: Study Day 1 through End of Study, assessed up to 45 days
  description: Incidence of SAEs and overall AEs coded in MedDRA
  measure: Incidence of serious adverse events (SAEs) and overall adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)
  time frame: Study Day 1 through End of Study, assessed up to 45 days
  description: Incidence of SAEs and overall AEs graded using the NCI CTCAE v5.0
  measure: Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Percentage of NK cells
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Percentage of NK cells as measured by flow cytometry.
  measure: Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Immune profile
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Function and cell receptor profile of NK cells as measured by intracellular staining for cytokines, surface marker staining and assessments of cytotoxicity.
  measure: Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Serum cytokines
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Serum Cytokines
  measure: Evaluate + compare the ex vivo expansion + enrichment of NK cells collected by apheresis without N-803 (unstimulated) + with N-803 administration (stimulated) via frequency, number, and phenotype of immune cells measured by flow + mass cytometry.
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Frequency, number, and phenotype of immune cells as measured by flow and mass cytometry.
  measure: Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated) via Number of days to manufacture CENK and M-CENK.
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Number of days to manufacture CENK and M-CENK.
  measure: Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated via Quality of CENK and M-CENK cells manufactured.
  time frame: Study Day 1 through Study Day 24, assessed up to 24 days
  description: - Quality of CENK and M-CENK cells manufactured measured by the percentage of CD56 adequate for infusion.
  arm group label: Healthy Subjects
  arm group type: Experimental
  description: Subjects will be scheduled for first apheresis collection on study Day 1. All subjects will receive N-803 at a fixed dose of 1 mg by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection.
  intervention type: Drug
  intervention name: N-803
  description: fixed dose of 1 mg by subcutaneous (SC) injection
  arm group label: Healthy Subjects
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Leonard Sender, MD
  role: Study Director
  affiliation: ImmunityBio, Inc.
  last name: Lauren Wilkins
  phone: 310-882-9593
  email: lauren.wilkins@immunitybio.com
  last name: Jayson Garmizo
  phone: 310-912-2230
  email: jayson.garmizo@immunitybio.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor