<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/NCT03815084</url>
  </required_header>
  <id_info>
    <org_study_id>PD-1/DC-NK YNYY-01</org_study_id>
    <nct_id>NCT03815084</nct_id>
  </id_info>
  <brief_title>A Study of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors</brief_title>
  <official_title>Clinical Study on the Safety and Efficacy of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allife Medical Science and Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First People's Hospital of Yunan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allife Medical Science and Technology Co., Ltd.</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>
      clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of&#xD;
      solid tumors&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>Early 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>occurrence of treatment related adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>PD-1 and DC-NK treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pd-1 and DC-NK cells</intervention_name>
    <description>total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .</description>
    <arm_group_label>PD-1 and DC-NK treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Previously receiving ≥ first-line regimen chemotherapy;&#xD;
&#xD;
          2. Age over 3 years old and less than 14 years old;&#xD;
&#xD;
          3. The expected survival period is more than 3 months;&#xD;
&#xD;
          4. ECOG≤2;&#xD;
&#xD;
          5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection&#xD;
             fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%;&#xD;
             creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3&#xD;
             times the normal range, total bilirubin ≤ 2.0 mg / dl;&#xD;
&#xD;
          6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L; There are measurable target&#xD;
             lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Liver and kidney function:&#xD;
&#xD;
               -  Total bilirubin &gt; 2 x ULN (Gilbert syndrome &gt; 3 x ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &gt; 3 × ULN&#xD;
&#xD;
               -  Serum creatinine clearance &gt;60mL/min&#xD;
&#xD;
          2. Serological examination:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &lt;0.75x109/L&#xD;
&#xD;
               -  Platelet count (PLT) &lt;50x109/L&#xD;
&#xD;
          3. Active hepatitis B (HBV-DNA &gt; 1000 copies / ml), hepatitis C, or uncontrolled&#xD;
             infection;&#xD;
&#xD;
          4. The number of days of chemotherapy medication and the administration of hormones below&#xD;
             5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5;&#xD;
&#xD;
          5. Active CNS disease (tumor cells in CSF);&#xD;
&#xD;
          6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular&#xD;
             internal coagulation;&#xD;
&#xD;
          7. creatinine &gt; 1.5 times the upper limit of normal or ALT / AST &gt; 3 times the upper&#xD;
             limit of normal or bilirubin &gt; 2 times the upper limit of normal;&#xD;
&#xD;
          8. The New York Heart Association (NYHA) is classified as Level III or higher;&#xD;
&#xD;
          9. Uncontrolled diabetes;&#xD;
&#xD;
         10. With other uncontrolled diseases, the investigator believes that it is not suitable&#xD;
             for joining;&#xD;
&#xD;
         11. Any situation that the investigator believes may increase the risk of the subject or&#xD;
             interfere with the test results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</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>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03815084
org study id: PD-1/DC-NK YNYY-01
nct id: NCT03815084
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of
      solid tumors
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: occurrence of treatment related adverse events
time frame: 1 year
description: occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
arm group label: PD-1 and DC-NK treatment group
arm group type: Experimental
intervention type: Drug
intervention name: pd-1 and DC-NK cells
description: total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .
arm group label: PD-1 and DC-NK treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No