<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/NCT03258047</url>
  </required_header>
  <id_info>
    <org_study_id>lymphoma center Q002</org_study_id>
    <nct_id>NCT03258047</nct_id>
  </id_info>
  <brief_title>Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma</brief_title>
  <official_title>Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It's a single arm, open label prospective study, in which the safety and efficacy of&#xD;
      autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.&#xD;
&#xD;
      Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 13, 2019</primary_completion_date>
  <phase>Phase 2</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>complete remission rate</measure>
    <time_frame>every 3 months until 20 months after the last patient's enrollment</time_frame>
    <description>complete remission rate after treated by CAR-T therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment</time_frame>
    <description>from date of inclusion to date of progression, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>20 months after the last patient's enrollment</time_frame>
    <description>from the date of inclusion to date of death, irrespective of cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>from the date of the start of treatment to 20 months after last patient's enrollment</time_frame>
    <description>any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the modified T cells by CAR-T in the patients</measure>
    <time_frame>from the date of re-transfusison to 20 months after last patient's enrollment</time_frame>
    <description>time from re-transfusion to date when the modified T cells become non-detectable.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>CAR-T treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>CAR-T</intervention_name>
    <description>CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.</description>
    <arm_group_label>CAR-T treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥18 years, male or female;&#xD;
&#xD;
          2. Karnofsky≥60%；&#xD;
&#xD;
          3. B cell lymphoma patients who are not available for the following treatment: autologous&#xD;
             stem cell transplantation, allogeneic stem cell transplantation, or patients with&#xD;
             short expected survival (less than 2 years).&#xD;
&#xD;
          4. Patients with CR2 or CR3 and no stem cell transplantation available due to age,&#xD;
             disease condition, lack of donors or any other reasons.&#xD;
&#xD;
          5. Patients have had more than 2 combined chemotherapy regimens;&#xD;
&#xD;
          6. Creatinin &lt;2.5mg/dL；ALT/AST level &lt;3 times of the maximum of normal range;&#xD;
             bilirubin&lt;3mg/dL；&#xD;
&#xD;
          7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;&#xD;
&#xD;
          8. Patient that could understand and is willing to sign the written consent;&#xD;
&#xD;
          9. Fertile female patient should be willing to take contraceptive measures.&#xD;
&#xD;
         10. Patient that is willing to follow up till at least 2 months after T cell&#xD;
             re-transfusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who need ≥15mg prednisone daily due to any cause;&#xD;
&#xD;
          2. Patients with autoimmune disease and need immunosuppressor treatment;&#xD;
&#xD;
          3. Serum creatinin&gt;2.5 mg/dL；serum AST &gt;5 times of normal maximum; bilirubin &gt;3 mg/Dl;&#xD;
&#xD;
          4. FEV1&lt;2 L，diffusion capacity for carbon monoxide of lung (DLCO) &lt;40%；&#xD;
&#xD;
          5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV&#xD;
             congestive heart failure, severe clinical hypotention; uncontrollable carotid heart&#xD;
             disease; or ejection fraction&lt;35%；&#xD;
&#xD;
          6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;&#xD;
&#xD;
          7. Patients that have previously received gene therapy of any kind;&#xD;
&#xD;
          8. Obvious clinical encephalopathy or novel neuron function damage;&#xD;
&#xD;
          9. Patients with active infection;&#xD;
&#xD;
         10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month&#xD;
             prior to enrollment or are currently under these treatment;&#xD;
&#xD;
         11. Patients who had allergic history to agents of the similar structure as CAR-T;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The first affiliated hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Zhejiang University</investigator_affiliation>
    <investigator_full_name>Wenbin Qian</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the data would be available on the corresponding website of the leading research center.</ipd_description>
  </patient_data>
  <!-- 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/NCT03258047
org study id: lymphoma center Q002
nct id: NCT03258047
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It's a single arm, open label prospective study, in which the safety and efficacy of
      autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

      Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete remission rate
time frame: every 3 months until 20 months after the last patient's enrollment
description: complete remission rate after treated by CAR-T therapy
measure: progression free survival
time frame: from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment
description: from date of inclusion to date of progression, relapse, or death from any cause
measure: overall survival
time frame: 20 months after the last patient's enrollment
description: from the date of inclusion to date of death, irrespective of cause
measure: adverse events
time frame: from the date of the start of treatment to 20 months after last patient's enrollment
description: any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
measure: duration of the modified T cells by CAR-T in the patients
time frame: from the date of re-transfusison to 20 months after last patient's enrollment
description: time from re-transfusion to date when the modified T cells become non-detectable.
arm group label: CAR-T treatment
arm group type: Experimental
description: In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
intervention type: Combination Product
intervention name: CAR-T
description: CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
arm group label: CAR-T treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Zhejiang University
investigator full name: Wenbin Qian
investigator title: Doctor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
sharing ipd: Yes
ipd description: All the data would be available on the corresponding website of the leading research center.