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/NCT05990920</url>
    </required_header>
    <id_info>
      <org_study_id>SNK02-202</org_study_id>
      <nct_id>NCT05990920</nct_id>
    </id_info>
    <brief_title>Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy</brief_title>
    <official_title>A Phase 1, Open-Label, Dose Escalation Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Participants With Pathologically Confirmed Cancer Refractory to Conventional Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NKGen Biotech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NKGen Biotech, 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>
        The goal of this clinical trial is to test SNK02 in participants with pathologically&#xD;
        confirmed cancer that is refractory to conventional therapy. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Is SNK02 safety and tolerable when administered weekly as an intravenous infusion&#xD;
  &#xD;
          -  What is the maximum dose that is tolerated of SNK02 Participants will be administered&#xD;
             SNK02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical&#xD;
             safety data for the treatment of cancer with allogeneic NK cells as a monotherapy&#xD;
             treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs</measure>
      <time_frame>4 weeks</time_frame>
      <description>Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MTD and/or RP2D</measure>
      <time_frame>8 weeks</time_frame>
      <description>Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>12 weeks</time_frame>
      <description>Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Pathologically Confirmed Cancer Refractory to Conventional Therapy</condition>
    <condition>Refractory Cancer</condition>
    <condition>Metastatic Cancer</condition>
    <condition>Recurrent Cancer</condition>
    <condition>Solid Tumor, Adult</condition>
    <condition>Solid Tumor</condition>
    <condition>Advanced Cancer</condition>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SNK02 will be administered as an IV infusion weekly for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>SNK02</intervention_name>
      <description>SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.</description>
      <arm_group_label>Cohort 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathologically confirmed diagnosis of refractory cancer that has failed at least prior&#xD;
               line of conventional standard of care therapy.&#xD;
  &#xD;
            -  Diagnosed with any histologically confirmed malignancy whose disease is confirmed to&#xD;
               be metastatic and/or unresectable for which standard curative or beneficial treatments&#xD;
               are no longer effective.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
  &#xD;
            -  ≥ 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat&#xD;
               the underlying malignancy (standard or investigational).&#xD;
  &#xD;
            -  ≥ 2 weeks since prior palliative radiotherapy.&#xD;
  &#xD;
            -  Complete recovery to baseline or Grade 1 NCI CTCAE v5.0 from AE of prior surgery,&#xD;
               radiotherapy, endocrine therapy, and other therapy as applicable, with exception of&#xD;
               grade 2 alopecia from prior chemotherapy.&#xD;
  &#xD;
            -  Adequate bone marrow function:&#xD;
  &#xD;
                 -  Neutrophils: ≥ 1.5 K/µL without colony-stimulating factor support&#xD;
  &#xD;
                 -  Platelet Count: ≥ 100 K/µL&#xD;
  &#xD;
                 -  Hemoglobin: ≥ 9.0 g/dL without need for hematopoietic growth factor or&#xD;
                    transfusion support&#xD;
  &#xD;
                 -  No ongoing transfusion requirements&#xD;
  &#xD;
            -  Adequate hepatic function:&#xD;
  &#xD;
                 -  Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply to&#xD;
                    patients with Gilbert's syndrome&#xD;
  &#xD;
                 -  Serum albumin ≥ 3.0 g/dL&#xD;
  &#xD;
                 -  ALT and AST ≤ 2.5 × ULN, unless hepatic metastases are present then &lt; 5 x ULN&#xD;
  &#xD;
            -  Adequate renal function with creatinine ≤ 2.0 mg/dL.&#xD;
  &#xD;
            -  Coagulation: INR or aPTT ≤1.5 X ULN unless the subject is receiving anticoagulant&#xD;
               therapy.&#xD;
  &#xD;
            -  Adequate pulmonary function as assessed by pulse oximetry (&gt;92% oxygen saturation on&#xD;
               room air).&#xD;
  &#xD;
            -  Negative pregnancy test for women of childbearing potential (i.e., all women except&#xD;
               those who are post menopause for ≥ 1 year or who have a history of hysterectomy or&#xD;
               surgical sterilization) and agree to use of effective contraception (hormonal or&#xD;
               barrier method of birth control) during study.&#xD;
  &#xD;
            -  Male participants and female participants of childbearing potential who engage in&#xD;
               heterosexual intercourse must agree to use protocol specified method(s) of&#xD;
               contraception&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant and/or lactating females.&#xD;
  &#xD;
            -  Life expectancy of less than three months.&#xD;
  &#xD;
            -  Currently being treated by &quot;biological therapy&quot; as defined by the National Cancer&#xD;
               Institute&#xD;
               (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-&#xD;
               sheet) Examples include checkpoint inhibitors, adoptive cell transfer, monoclonal&#xD;
               antibodies, treatment vaccines, cytokines, CAR-T therapy, and natural killer (NK) cell&#xD;
               therapy.&#xD;
  &#xD;
            -  Participants that are actively positive for COVID.&#xD;
  &#xD;
            -  Autoimmune disease requiring therapy; immunodeficiency, or any disease process&#xD;
               requiring immunosuppressive therapy, with exception to the following:&#xD;
  &#xD;
                 -  intranasal, inhaled, topical steroids, or local steroid injection (e.g.,&#xD;
                    intra-articular injection);&#xD;
  &#xD;
                 -  Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or&#xD;
                    equivalent;&#xD;
  &#xD;
                 -  Steroids as premedication for hypersensitivity reactions (e.g., CT scan&#xD;
                    premedication).&#xD;
  &#xD;
            -  Prior clinical trial requiring participant to receive an investigational drug within&#xD;
               four weeks of enrollment.&#xD;
  &#xD;
            -  Live vaccine within 30 days prior to enrollment.&#xD;
  &#xD;
            -  Clinically significant (i.e., active) cardiovascular disease: cerebral vascular&#xD;
               accident/stroke (&lt; 6 months prior to enrollment), myocardial infarction (&lt; 6 months&#xD;
               prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart&#xD;
               Association Classification Class II), or serious cardiac arrhythmia requiring&#xD;
               medication.&#xD;
  &#xD;
            -  Mental or psychological illness preventing cooperation with treatment, efficacy&#xD;
               evaluations.&#xD;
  &#xD;
            -  Participants who have undergone prior organ transplantation, including allogeneic&#xD;
               stem-cell transplantation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Study Director</last_name>
      <phone>949-396-6830</phone>
      <email>trials@nkgenbiotech.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sarcoma Oncology Center</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90403</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vicky Chua, MD</last_name>
        <phone>310-552-9999</phone>
      </contact>
      <investigator>
        <last_name>Sant Chawla, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Recurrence</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/NCT05990920
  org study id: SNK02-202
  nct id: NCT05990920
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to test SNK02 in participants with pathologically
        confirmed cancer that is refractory to conventional therapy. The main questions it aims to
        answer are:
  
          -  Is SNK02 safety and tolerable when administered weekly as an intravenous infusion
  
          -  What is the maximum dose that is tolerated of SNK02 Participants will be administered
             SNK02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical
             safety data for the treatment of cancer with allogeneic NK cells as a monotherapy
             treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
  time frame: 4 weeks
  description: Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
  measure: MTD and/or RP2D
  time frame: 8 weeks
  description: Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  time frame: 12 weeks
  description: Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
  arm group label: Cohort 1
  arm group type: Experimental
  description: SNK02 will be administered as an IV infusion weekly for 8 weeks.
  intervention type: Biological
  intervention name: SNK02
  description: SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.
  arm group label: Cohort 1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  phone: 949-396-6830
  email: trials@nkgenbiotech.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Recurrence
  sharing ipd: No