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/NCT06015269</url>
    </required_header>
    <id_info>
      <org_study_id>BZT003-A-01</org_study_id>
      <nct_id>NCT06015269</nct_id>
    </id_info>
    <brief_title>Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery</brief_title>
    <official_title>Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery</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>
        This is an exploratory study on the safety, immune response, and preliminary effectiveness of&#xD;
        single arm, fixed dose therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a clinical study exploring the safety, immune response, and preliminary&#xD;
        efficacy of a single arm, 1x107cells dose.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dose-limiting toxicity</measure>
      <time_frame>within 1 months of single injection</time_frame>
      <description>Safety</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>DC cells</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Super DC Vaccine (DC)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DC cells</intervention_name>
      <description>At a single arm, 1x107cells dose</description>
      <arm_group_label>DC cells</arm_group_label>
      <other_name>Super DC Vaccine (DC)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-80 years old, weight ≥ 40kg; No gender limit;&#xD;
  &#xD;
            2. Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing&#xD;
               radical resection surgery;&#xD;
  &#xD;
            3. At the beginning of the study (after surgery), there were no lesions, no local&#xD;
               recurrence or distant metastasis on the imaging, and no brain metastasis (images&#xD;
               within one month before enrollment can be used for screening);&#xD;
  &#xD;
            4. Subjects in the safety verification stage need to provide immunohistochemical test&#xD;
               results with positive expression of Survivin or P53;&#xD;
  &#xD;
            5. ECOG score 0-1 points;&#xD;
  &#xD;
            6. There are sufficient venous channels and no contraindications for peripheral blood&#xD;
               mononuclear cell collection surgery;&#xD;
  &#xD;
            7. Organs and bone marrow function well:&#xD;
  &#xD;
                 1. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by&#xD;
                    echocardiography within one month of enrollment; The electrocardiogram is&#xD;
                    basically normal;&#xD;
  &#xD;
                 2. Platelets ≥ 90 × 10 ^ 9/L;&#xD;
  &#xD;
                 3. Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7&#xD;
                    days);&#xD;
  &#xD;
                 4. Total bilirubin ≤ 2 times the upper limit of normal value;&#xD;
  &#xD;
                 5. Serum creatinine ≤ 1.5 times the upper limit of normal value;&#xD;
  &#xD;
                 6. Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver&#xD;
                    cancer is 5 times the upper limit of normal value);&#xD;
  &#xD;
                 7. International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the&#xD;
                    upper limit of normal value;&#xD;
  &#xD;
                 8. Pulmonary function: ≤ CTCAE level 1 dyspnea and SaO2 ≥ 91% in indoor air&#xD;
                    environment;&#xD;
  &#xD;
            8. Able to understand trial requirements and matters, willing to participate in clinical&#xD;
               research according to trial requirements;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. HIV and syphilis serological reactions were positive; Hepatitis B surface antigen is&#xD;
               positive, hepatitis B core antibody is positive, and the copy number of hepatitis B&#xD;
               virus DNA is higher than the lower limit of detection and or greater than or equal to&#xD;
               1000 copies/ml; Or hepatitis C virus infected individuals;&#xD;
  &#xD;
            2. Any uncontrollable active infection, coagulation disorder, or any other major disease;&#xD;
  &#xD;
            3. Pregnant or lactating women&#xD;
  &#xD;
            4. Suffering from active neuroautoimmune or inflammatory diseases, such as any of the&#xD;
               following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing&#xD;
               spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving&#xD;
               relevant treatment; Subjects who are still using immunosuppressants for organ&#xD;
               transplantation; Or subjects who have been using immunosuppressive drugs such as&#xD;
               glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe&#xD;
               allergic constitution;&#xD;
  &#xD;
            5. Subjects with existing abnormalities in the central nervous system, such as seizures,&#xD;
               cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune&#xD;
               diseases associated with central nervous system involvement;&#xD;
  &#xD;
            6. Major cardiovascular diseases with clinical significance include:&#xD;
  &#xD;
               Symptomatic congestive heart failure&#xD;
  &#xD;
               B Unstable angina pectoris&#xD;
  &#xD;
               Severe arrhythmia requiring medication treatment&#xD;
  &#xD;
               Uncontrolled hypertension&#xD;
  &#xD;
               Myocardial infarction or ventricular arrhythmia within 6 months prior to screening&#xD;
  &#xD;
            7. Other situations where researchers believe it is not suitable to participate in&#xD;
               clinical trials.&#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_official>
      <last_name>Lou jinxing</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanghai Mengchao Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lou jinxing</last_name>
      <phone>18911335396</phone>
      <email>loujx@shcell.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhang yan</last_name>
      <phone>18616657339</phone>
      <email>yan.zhang@shcell.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Mengchao Cancer Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lou jinxing</last_name>
      </contact>
      <contact_backup>
        <last_name>Zhang yan</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Solid tumor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <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/NCT06015269
  org study id: BZT003-A-01
  nct id: NCT06015269
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is an exploratory study on the safety, immune response, and preliminary effectiveness of
        single arm, fixed dose therapy
  This study is a clinical study exploring the safety, immune response, and preliminary
        efficacy of a single arm, 1x107cells dose.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Dose-limiting toxicity
  time frame: within 1 months of single injection
  description: Safety
  arm group label: DC cells
  arm group type: Experimental
  description: Super DC Vaccine (DC)
  intervention type: Drug
  intervention name: DC cells
  description: At a single arm, 1x107cells dose
  arm group label: DC cells
  other name: Super DC Vaccine (DC)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Lou jinxing
  role: Principal Investigator
  affiliation: Shanghai Mengchao Cancer Hospital
  last name: Lou jinxing
  phone: 18911335396
  email: loujx@shcell.com
  last name: Zhang yan
  phone: 18616657339
  email: yan.zhang@shcell.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Recurrence
  mesh term: Vaccines
  sharing ipd: Yes
  ipd info type: Clinical Study Report (CSR)