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/NCT06041815</url>
    </required_header>
    <id_info>
      <org_study_id>gut microbiota + CAR-T</org_study_id>
      <nct_id>NCT06041815</nct_id>
    </id_info>
    <brief_title>Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies</brief_title>
    <official_title>A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Soochow University</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>
        The purpose of this prospective and observational study is to evaluate the correlation&#xD;
        between gut microbiota and clinical response to CAR-T treatment for hematological&#xD;
        malignancies&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in&#xD;
        hematological malignancies. However, response rates and associated immune-related adverse&#xD;
        effects widely vary among patients. And no biomarkers have been identified to predict the&#xD;
        efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical&#xD;
        experiments and clinical studies have shown that gut microbiota was associated with the&#xD;
        efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic&#xD;
        malignancies, gut microbiota was associated with the development of graft-versus-host disease&#xD;
        (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the&#xD;
        potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy&#xD;
        is unclear. Therefore, in this study, we aim to evaluate the correlation between gut&#xD;
        microbiota and clinical response to CAR-T treatment for hematological malignancies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 3, 2023</start_date>
    <completion_date type="Anticipated">March 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>gut microbiota</measure>
      <time_frame>From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion</time_frame>
      <description>diversity and composition of the gut microbiota</description>
    </primary_outcome>
    <primary_outcome>
      <measure>efficacy of CAR-T therapy</measure>
      <time_frame>six months</time_frame>
      <description>CR，PR and NR</description>
    </primary_outcome>
    <primary_outcome>
      <measure>toxicity of CAR-T therapy</measure>
      <time_frame>six months</time_frame>
      <description>Adverse events are evaluated with CTCAE V5.0</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hematological Malignancies</condition>
    <condition>Chimeric Antigen Receptor T-cell Therapy</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        feces&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with hematological malignancies who were proposed for CAR-T treatment at the First&#xD;
          Affiliated Hospital of Soochow University were enrolled in our study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 16-65 years.&#xD;
  &#xD;
            2. Hematologic malignancies intended for CAR-T therapy.&#xD;
  &#xD;
            3. Expected survival time ≥ 3 months (according to investigator's judgement).&#xD;
  &#xD;
            4. Left ventricular ejection fractions ≥ 55% by echocardiography.&#xD;
  &#xD;
            5. ALT / AST &lt;3 times of normal amounts.&#xD;
  &#xD;
            6. Creatinine&lt;2.0mg/dl.&#xD;
  &#xD;
            7. PT and APPT &lt;2 times of normal amounts.&#xD;
  &#xD;
            8. Karnofsky performance status ≥ 60.&#xD;
  &#xD;
            9. The ECOG score ≤2 points.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant (or lactating) women;&#xD;
  &#xD;
            2. Uncontrolled active infection；&#xD;
  &#xD;
            3. Active infection of hepatitis B virus or hepatitis C virus；&#xD;
  &#xD;
            4. Human immunodeficiency virus (HIV) positive；&#xD;
  &#xD;
            5. Patients with a history of myocardial infarction or severe arrhythmia within six&#xD;
               months or those with class III or IV cardiac function according to the New York&#xD;
               classification；&#xD;
  &#xD;
            6. Any situations that the investigator believes may increase the risk of patients or&#xD;
               interfere with the results of study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaowen Tang, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital of Soochow University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaowen Tang, PhD</last_name>
      <phone>86-512-67781525</phone>
      <email>xwtang1020@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Depei Wu, PhD</last_name>
      <phone>86-512-67781856</phone>
      <email>wudepei@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaowen Tang, PhD</last_name>
        <phone>+8651267781525</phone>
        <email>xwtang1020@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Depei Wu, PhD</last_name>
        <phone>+8651267781856</phone>
        <email>wudepei@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>gut microbiota, CAR-T</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Hematologic Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06041815
  org study id: gut microbiota + CAR-T
  nct id: NCT06041815
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this prospective and observational study is to evaluate the correlation
        between gut microbiota and clinical response to CAR-T treatment for hematological
        malignancies
  Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in
        hematological malignancies. However, response rates and associated immune-related adverse
        effects widely vary among patients. And no biomarkers have been identified to predict the
        efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical
        experiments and clinical studies have shown that gut microbiota was associated with the
        efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic
        malignancies, gut microbiota was associated with the development of graft-versus-host disease
        (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the
        potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy
        is unclear. Therefore, in this study, we aim to evaluate the correlation between gut
        microbiota and clinical response to CAR-T treatment for hematological malignancies.
  observational model: Cohort
  time perspective: Prospective
  measure: gut microbiota
  time frame: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
  description: diversity and composition of the gut microbiota
  measure: efficacy of CAR-T therapy
  time frame: six months
  description: CR，PR and NR
  measure: toxicity of CAR-T therapy
  time frame: six months
  description: Adverse events are evaluated with CTCAE V5.0
  feces
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Xiaowen Tang, PhD
  role: Study Chair
  affiliation: The First Affiliated Hospital of Soochow University
  last name: Xiaowen Tang, PhD
  phone: 86-512-67781525
  email: xwtang1020@163.com
  last name: Depei Wu, PhD
  phone: 86-512-67781856
  email: wudepei@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Hematologic Neoplasms