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/NCT06036355</url>
    </required_header>
    <id_info>
      <org_study_id>CH2301-A-03</org_study_id>
      <nct_id>NCT06036355</nct_id>
    </id_info>
    <brief_title>The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)</brief_title>
    <official_title>THE Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Cell Therapy Group Co.,Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Cell Therapy Group Co.,Ltd</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral&#xD;
        NMN combined with DC cells injection in patients after tumor surgery, and evaluate the&#xD;
        biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS,&#xD;
        antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative&#xD;
        tumor patients who meet the entry and excretion criteria were recruited to explore the&#xD;
        clinical potential of NMN combined with DC cell vaccine.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Concentration of double antibodies in peripheral blood</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of NMN (nicotinamide mononucleotide) in peripheral blood</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Peripheral blood NAD+</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>T cell depletion index (PD1/Tim-3/lag3)</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>T cell activation index CD107</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>T cell and NK cell function index (INF- γ) and granzyme</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>High quality Survival benefit Endpoint (DFS)</measure>
      <time_frame>Up to 15 years</time_frame>
      <description>DFS refers to the time from the beginning of treatment to the recurrence of the disease or the death of the patient. Patients need to be followed up regularly to keep records.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Survival benefit (OS)</measure>
      <time_frame>Up to 15 years</time_frame>
      <description>OS refers to the time from the beginning of randomization to death (for any reason). Patients need to be followed up regularly to keep records.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distant Metastasis-Free Survival (DMFS)</measure>
      <time_frame>Up to 15 years</time_frame>
      <description>Metastasis-free survival time. Patients need to be followed up regularly to keep records.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Postoperative Prevention of Tumor</condition>
    <arm_group>
      <arm_group_label>Orally take NMN (Vital NAD) combined with DC cell vaccine injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The arm is a combination of two drugs. The first NMN is a precursor of NAD+, which is used orally. DC vaccine is a kind of immune cells expanded in vitro and used by injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral NMN combined with DC cell vaccine</intervention_name>
      <description>The whole intervention cycle was treated with NMN (Vital NAD) 600mg/day for at least 50 days. During this period, the first DC cell injection was given on the 10th day, and then another DC cell injection was given at 2 weeks, 4 weeks and 6 weeks after the first injection.</description>
      <arm_group_label>Orally take NMN (Vital NAD) combined with DC cell vaccine injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. 18-80 years old, weight ≥ 40kg.&#xD;
  &#xD;
            -  2. Patients with malignant solid tumors diagnosed by histology or cytology, who&#xD;
               underwent radical resection and completed standard postoperative adjuvant therapy.&#xD;
  &#xD;
            -  3. Estimated survival time ≥ 6 months.&#xD;
  &#xD;
            -  4. ECOG score 0-1.&#xD;
  &#xD;
            -  5. Adequate venous channels, there is no contraindication for peripheral blood&#xD;
               monocyte collection.&#xD;
  &#xD;
            -  6. Good function of organs and bone marrow.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Diabetes.&#xD;
  &#xD;
            -  2. Premenopausal or menopause &lt;1 year.&#xD;
  &#xD;
            -  3. Persons who have received hormone replacement therapy within the past 6 months.&#xD;
  &#xD;
            -  4. Persons who take vitamin B supplementation and are not willing to discontinue&#xD;
               supplementation for 3 weeks before and during the entire study period.&#xD;
  &#xD;
            -  5. Unstable weight (&gt;3% change during the last 2 months before entering the study).&#xD;
  &#xD;
            -  6. Significant organ system dysfunction or disease.&#xD;
  &#xD;
            -  7. Polycystic ovary syndrome.&#xD;
  &#xD;
            -  8. Major psychiatric illness.&#xD;
  &#xD;
            -  9. Use of medications known to affect study outcome measures (e.g., steroid) or&#xD;
               increase the risk of study procedures (e.g., anticoagulants) that cannot be&#xD;
               temporarily discontinued for the study.&#xD;
  &#xD;
            -  10. Metal implants.&#xD;
  &#xD;
            -  11. Persons who consume &gt;14 units of alcohol per week.&#xD;
  &#xD;
            -  12. Unable or unwilling to follow the study protocol or who, for any reason, is&#xD;
               considered an inappropriate candidate for the study by the research team.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jinxing Lou</last_name>
      <phone>+86-18911335396</phone>
      <email>loujx@shcell.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shuan Liu</last_name>
      <phone>+8617749122881</phone>
      <email>liushuan@shcell.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Mengchao Cancer Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200240</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jinxing Lou</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </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/NCT06036355
  org study id: CH2301-A-03
  nct id: NCT06036355
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral
        NMN combined with DC cells injection in patients after tumor surgery, and evaluate the
        biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS,
        antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative
        tumor patients who meet the entry and excretion criteria were recruited to explore the
        clinical potential of NMN combined with DC cell vaccine.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Concentration of double antibodies in peripheral blood
  time frame: Up to 3 months
  measure: Concentration of NMN (nicotinamide mononucleotide) in peripheral blood
  time frame: Up to 3 months
  measure: Peripheral blood NAD+
  time frame: Up to 3 months
  measure: Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)
  time frame: Up to 3 months
  measure: T cell depletion index (PD1/Tim-3/lag3)
  time frame: Up to 3 months
  measure: T cell activation index CD107
  time frame: Up to 3 months
  measure: T cell and NK cell function index (INF- γ) and granzyme
  time frame: Up to 3 months
  measure: High quality Survival benefit Endpoint (DFS)
  time frame: Up to 15 years
  description: DFS refers to the time from the beginning of treatment to the recurrence of the disease or the death of the patient. Patients need to be followed up regularly to keep records.
  measure: Survival benefit (OS)
  time frame: Up to 15 years
  description: OS refers to the time from the beginning of randomization to death (for any reason). Patients need to be followed up regularly to keep records.
  measure: Distant Metastasis-Free Survival (DMFS)
  time frame: Up to 15 years
  description: Metastasis-free survival time. Patients need to be followed up regularly to keep records.
  arm group label: Orally take NMN (Vital NAD) combined with DC cell vaccine injection
  arm group type: Experimental
  description: The arm is a combination of two drugs. The first NMN is a precursor of NAD+, which is used orally. DC vaccine is a kind of immune cells expanded in vitro and used by injection.
  intervention type: Drug
  intervention name: Oral NMN combined with DC cell vaccine
  description: The whole intervention cycle was treated with NMN (Vital NAD) 600mg/day for at least 50 days. During this period, the first DC cell injection was given on the 10th day, and then another DC cell injection was given at 2 weeks, 4 weeks and 6 weeks after the first injection.
  arm group label: Orally take NMN (Vital NAD) combined with DC cell vaccine injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jinxing Lou
  phone: +86-18911335396
  email: loujx@shcell.com
  last name: Shuan Liu
  phone: +8617749122881
  email: liushuan@shcell.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd info type: Clinical Study Report (CSR)