<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/NCT03815630</url>
  </required_header>
  <id_info>
    <org_study_id>PD-1/DC CIK-YNYY-01</org_study_id>
    <nct_id>NCT03815630</nct_id>
  </id_info>
  <brief_title>A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors</brief_title>
  <acronym>DC-CIK</acronym>
  <official_title>Clinical Study on the Safety and Efficacy of Pd-1 Combined With Dc-cik 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 Yunnan 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>
      This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1&#xD;
      and DC-CIK with anti-solid tumor&#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-cik 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-cik cells</intervention_name>
    <description>Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK cells at day3 .</description>
    <arm_group_label>PD-1 and dc-cik 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;&#xD;
&#xD;
          7. There are measurable target 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/NCT03815630
org study id: PD-1/DC CIK-YNYY-01
nct id: NCT03815630
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1
      and DC-CIK with anti-solid tumor
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-cik treatment group
arm group type: Experimental
intervention type: Drug
intervention name: pd-1 and dc-cik cells
description: Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK cells at day3 .
arm group label: PD-1 and dc-cik 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