<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/NCT04448509</url>
  </required_header>
  <id_info>
    <org_study_id>BHCT-TCELL-04</org_study_id>
    <nct_id>NCT04448509</nct_id>
  </id_info>
  <brief_title>Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study</brief_title>
  <official_title>Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>He Huang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanjing Bioheng Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang University</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>
      Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T&#xD;
      cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Collect blood samples (whole blood and PBMC) from healthy donors for the development and&#xD;
      production of UCAR-T cells&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 18, 2020</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the number of PBMC count</measure>
    <time_frame>1 years</time_frame>
    <description>UCAR-T cell</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Peripheral Blood Mononuclear Cell</condition>
  <arm_group>
    <arm_group_label>Healthy donor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy donor</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peripheral blood mononuclear cell apheresis</intervention_name>
    <description>Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells</description>
    <arm_group_label>Healthy donor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged 18-40 years, no donation reaction in the past;&#xD;
&#xD;
          2. Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;&#xD;
&#xD;
          3. Blood pressure:12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60&#xD;
             mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg);&#xD;
&#xD;
          4. Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm;&#xD;
&#xD;
          5. Temperature: 36.3-37.2℃ (oral temperature);&#xD;
&#xD;
          6. Generally in good condition: no damage to important organs such as heart, lung, liver&#xD;
             and kidney; no severe or uncontrolled infection; no history of severe mental&#xD;
             disorders;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of&#xD;
             needles, faint, and Meniere's disease;&#xD;
&#xD;
          2. Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV&#xD;
             antibody positive;&#xD;
&#xD;
          3. History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the&#xD;
             clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3&#xD;
             consecutive times;&#xD;
&#xD;
          4. Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors&#xD;
             with simple urticaria who are not in acute attack are eligible to donate PBMC);&#xD;
&#xD;
          5. Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone&#xD;
             tuberculosis;&#xD;
&#xD;
          6. Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system&#xD;
             infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.);&#xD;
&#xD;
          7. Various hematological diseases (including anemia, leukemia, polycythemia vera and&#xD;
             various hemorrhagic and coagulative diseases);&#xD;
&#xD;
          8. Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes&#xD;
             insipidus, diabetes mellitus, etc.);&#xD;
&#xD;
          9. Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain&#xD;
             trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.);&#xD;
&#xD;
         10. Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis,&#xD;
             hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease,&#xD;
             etc.);&#xD;
&#xD;
         11. Malignancies and benign tumors affecting health;&#xD;
&#xD;
         12. Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important&#xD;
             organs;&#xD;
&#xD;
         13. Exposure to harmful substances or radioactive substances (except for clinical&#xD;
             radiology);&#xD;
&#xD;
         14. High-risk groups susceptible to HIV infection, such as drug users, homosexuals and&#xD;
             people with multiple sexual partners;&#xD;
&#xD;
         15. Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt disease (vCJD), family history,&#xD;
             and treatment with human and animal pituitary-derived substances (e.g. growth hormone,&#xD;
             gonadotropin, thyrotropin, etc.). Organ transplantation recipients (including cornea,&#xD;
             bone marrow, dura mater) may be exposed to bovine spongiform encephalopathy (BSE) and&#xD;
             vCJD;&#xD;
&#xD;
         16. Other diseases or conditions in which donors are ineligible to donate PBMC in the&#xD;
             opinion of physicians;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>He Huang, PhD</last_name>
    <phone>86-13605714822</phone>
    <phone_ext>86-13605714822</phone_ext>
    <email>huanghe@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jimin Shi, MD</last_name>
    <phone>86-13857119907</phone>
    <phone_ext>86-13857119907</phone_ext>
    <email>jiminshi@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Hospital of Zhejiang Medical Colleage Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>He Huang, PhD</last_name>
      <phone>86-13605714822</phone>
      <email>huanghe@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>He Huang</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04448509
org study id: BHCT-TCELL-04
nct id: NCT04448509
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T
      cells
Collect blood samples (whole blood and PBMC) from healthy donors for the development and
      production of UCAR-T cells
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: the number of PBMC count
time frame: 1 years
description: UCAR-T cell
arm group label: Healthy donor
arm group type: Other
description: Healthy donor
intervention type: Other
intervention name: Peripheral blood mononuclear cell apheresis
description: Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells
arm group label: Healthy donor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: He Huang, PhD
phone: 86-13605714822
phone ext: 86-13605714822
email: huanghe@zju.edu.cn
last name: Jimin Shi, MD
phone: 86-13857119907
phone ext: 86-13857119907
email: jiminshi@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Zhejiang University
investigator full name: He Huang
investigator title: Clinical Professor