<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/NCT04439721</url>
  </required_header>
  <id_info>
    <org_study_id>PG-γδT-001</org_study_id>
    <nct_id>NCT04439721</nct_id>
  </id_info>
  <brief_title>γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse</brief_title>
  <acronym>γδT</acronym>
  <official_title>Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PersonGen BioTherapeutics (Suzhou) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PersonGen BioTherapeutics (Suzhou) 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>
      Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia&#xD;
      Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      γδT cells belong to the innate immune system and have a powerful anti-tumor effect. Leukemia&#xD;
      patients transplanted with allogeneic hematopoietic stem cells have an important role in&#xD;
      controlling leukemia recurrence. Although adoptive immunotherapy using in vitro expanded γδT&#xD;
      cells has achieved significant results in patients with solid tumors, infusion of donor γδT&#xD;
      cells in leukemia patients undergoing allogeneic hematopoietic stem cell transplantation to&#xD;
      prevent leukemia recurrence has not been reported. . This clinical study intends to initially&#xD;
      observe the safety and effectiveness of donor γδT cell infusion to prevent&#xD;
      recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to&#xD;
      further improve the transplantation effect of these patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of the dose limiting toxicity (DLT)</measure>
    <time_frame>4 weeks after γδT infusion</time_frame>
    <description>Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of serious adverse events (SAEs)</measure>
    <time_frame>4 weeks after γδT infusion</time_frame>
    <description>The incidence of serious adverse events (SAEs) after γδT infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival time(DFS)</measure>
    <time_frame>about 2 years after γδT infusion</time_frame>
    <description>γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>about 2 years after γδT infusion</time_frame>
    <description>The time from the subject receiving γδT cell infusion treatment to death (for any reason)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of remission after administration (DOR)</measure>
    <time_frame>about 2 years after γδT infusion</time_frame>
    <description>γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Leukemia, B-cell</condition>
  <arm_group>
    <arm_group_label>γδT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>γδT Cell infusion agent</intervention_name>
    <description>γδT</description>
    <arm_group_label>γδT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute leukemia patients undergoing salvage allogeneic hematopoietic stem cell&#xD;
             transplantation&#xD;
&#xD;
          -  Age 10-65,Any gender&#xD;
&#xD;
          -  Expected lifetime&gt;3months&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  DSA Negative&#xD;
&#xD;
          -  Successful granulocyte implantation&#xD;
&#xD;
          -  Liver and kidney function, heart and lung function meet the following&#xD;
             requirements:①Creatinine≤1.5 ULN；②ALT/AST ≤5 ULN； ③Baseline oxygen saturation≥92%；&#xD;
             ④Left ventricular ejection fraction≥50%&#xD;
&#xD;
          -  Female subjects with fertility who had a negative pregnancy test within 48 hours&#xD;
             before the infusion and were not breastfeeding; all subjects with fertility potential&#xD;
             before enrolling in the study and throughout the study period until the last infusion&#xD;
             Within 3 months, take adequate contraceptive measures&#xD;
&#xD;
          -  Signing informed consent patients must be able to understand and be willing to&#xD;
             participate in this study, and sign informed consent at the same time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Donor HBsAg or HBcAb positive and HBV DNA titer test is not within the normal&#xD;
             reference value; donor or patient HCV antibody positive and peripheral blood HCV RNA&#xD;
             positive; donor or patient HIV antibody positive; donor syphilis test positive&#xD;
&#xD;
          -  Active central nervous system disease&#xD;
&#xD;
          -  BMI index&gt;35&#xD;
&#xD;
          -  Allergic to DMSO&#xD;
&#xD;
          -  Graft-versus-host disease&#xD;
&#xD;
          -  Septic shock&#xD;
&#xD;
          -  Systemic steroid therapy is required during cell infusion or cell collection, or there&#xD;
             are conditions that researchers believe may require steroid therapy during blood&#xD;
             collection or during infusion. In addition to cell collection or infusion, steroids&#xD;
             for disease treatment are allowed, and inhaled steroids or hydrocortisone are also&#xD;
             allowed for physiological replacement therapy in patients with adrenal insufficiency&#xD;
&#xD;
          -  Participated in another clinical trial within 4 weeks before enrolling in the study,&#xD;
             or intend to participate in another clinical trial throughout the study&#xD;
&#xD;
          -  According to the judgment of the investigator, it does not meet the situation of cell&#xD;
             preparation&#xD;
&#xD;
          -  Circumstances considered by other researchers to be inappropriate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suning Chen, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hematology，The First Affiliaated Hospital Of Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suning Chen, Ph.D</last_name>
    <phone>13814881746</phone>
    <email>chensuning@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaofei Yang, Ph.D</last_name>
    <phone>18962156841</phone>
    <email>yangxiaofei1977@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>No.188 Shizi Street</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaofei Yang, Ph.D</last_name>
      <phone>18962156841</phone>
      <email>yangxiaofei1977@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>γδT</keyword>
  <keyword>leukemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, B-Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT04439721
org study id: PG-γδT-001
nct id: NCT04439721
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia
      Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
γδT cells belong to the innate immune system and have a powerful anti-tumor effect. Leukemia
      patients transplanted with allogeneic hematopoietic stem cells have an important role in
      controlling leukemia recurrence. Although adoptive immunotherapy using in vitro expanded γδT
      cells has achieved significant results in patients with solid tumors, infusion of donor γδT
      cells in leukemia patients undergoing allogeneic hematopoietic stem cell transplantation to
      prevent leukemia recurrence has not been reported. . This clinical study intends to initially
      observe the safety and effectiveness of donor γδT cell infusion to prevent
      recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to
      further improve the transplantation effect of these patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Identification of the dose limiting toxicity (DLT)
time frame: 4 weeks after γδT infusion
description: Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
measure: The incidence of serious adverse events (SAEs)
time frame: 4 weeks after γδT infusion
description: The incidence of serious adverse events (SAEs) after γδT infusion
measure: Disease-free survival time(DFS)
time frame: about 2 years after γδT infusion
description: γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause
measure: Overall survival (OS)
time frame: about 2 years after γδT infusion
description: The time from the subject receiving γδT cell infusion treatment to death (for any reason)
measure: Duration of remission after administration (DOR)
time frame: about 2 years after γδT infusion
description: γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause
arm group label: γδT
arm group type: Experimental
description: γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.
intervention type: Drug
intervention name: γδT Cell infusion agent
description: γδT
arm group label: γδT
criteria: 
gender: All
minimum age: 10 Years
maximum age: 65 Years
healthy volunteers: No
last name: Suning Chen, Ph.D
role: Principal Investigator
affiliation: Hematology，The First Affiliaated Hospital Of Soochow University
last name: Suning Chen, Ph.D
phone: 13814881746
email: chensuning@sina.com
last name: Xiaofei Yang, Ph.D
phone: 18962156841
email: yangxiaofei1977@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, B-Cell