<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/NCT04440436</url>
  </required_header>
  <id_info>
    <org_study_id>SD45</org_study_id>
    <nct_id>NCT04440436</nct_id>
  </id_info>
  <brief_title>Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients</brief_title>
  <official_title>Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Immunochina Medical Science &amp; Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Simcere Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Immunochina Medical Science &amp; Technology 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 a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells&#xD;
      in adult with R/R Non-Hodgkins Lymphoma in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate&#xD;
      the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive&#xD;
      invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to&#xD;
      evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or&#xD;
      refractory CD19-positive invasion of non-Hodgkin's lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">June 4, 2035</completion_date>
  <primary_completion_date type="Anticipated">June 4, 2022</primary_completion_date>
  <phase>Phase 1/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>Objective Response Rate(ORR) at 90 days</measure>
    <time_frame>90 days</time_frame>
    <description>The primary endpoint was ORR 90 days after IM19 infusion</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>NHL</condition>
  <arm_group>
    <arm_group_label>IM19 CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IM19 CAR-T cells be administrated in two dose level</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IM19 CAR-T Cells</intervention_name>
    <description>IM19 CAR-T cells&#xD;
Drug: Fludarabine&#xD;
Two days before cell infusion, all patients will be treated with fludarabine for 3 days&#xD;
Drug: Cyclophosphamide&#xD;
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days</description>
    <arm_group_label>IM19 CAR-T cells</arm_group_label>
    <other_name>Fludarabine</other_name>
    <other_name>Cyclophosphamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by&#xD;
             CD19 positive cytology or histology, specific types.&#xD;
&#xD;
          -  CD20 positive patients undergo corresponding targeted therapy.&#xD;
&#xD;
          -  Patients must have evaluable evidence of disease (according to Lugano 2014 standards).&#xD;
&#xD;
          -  ≥ 18 years old.&#xD;
&#xD;
          -  The expected survival period is more than 3 months.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Women of childbearing age have a negative blood pregnancy test before the start of the&#xD;
             trial and agree to have effective contraceptive measures during the trial until the&#xD;
             last follow-up&#xD;
&#xD;
          -  Participate voluntarily in this experiment and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigators judged patients with gastrointestinal lymph nodes and/or central&#xD;
             nervous system involvement who may be at risk for CAR-T treatment.&#xD;
&#xD;
          -  Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer&#xD;
             from autoimmune disease&#xD;
&#xD;
          -  Subject has used chemotherapy or radiotherapy within three days before the blood&#xD;
             collection period.&#xD;
&#xD;
          -  Subject has used systemic steroid drugs within 5 days before the blood collection&#xD;
             period (except for recent or current inhaled steroids).&#xD;
&#xD;
          -  Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs&#xD;
             within 5 days before the blood collection&#xD;
&#xD;
          -  Subject has used any gene therapy products before.&#xD;
&#xD;
          -  Subject with a history of epilepsy or other central nervous system diseases.&#xD;
&#xD;
          -  Active Hepatitis B Virus or Hepatitis C Virus infections&#xD;
&#xD;
          -  The subject with other tumors in the past 5 years.&#xD;
&#xD;
          -  Within 14 days before enrollment, there was active infection or uncontrollable&#xD;
             infection requiring systemic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuqin Song, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fei Wu, MD</last_name>
    <phone>+8615801390058</phone>
    <email>wufei@immunochina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuqin Song, MD, PhD</last_name>
      <phone>+8618911576946</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04440436
org study id: SD45
nct id: NCT04440436
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells
      in adult with R/R Non-Hodgkins Lymphoma in China.
This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate
      the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive
      invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to
      evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or
      refractory CD19-positive invasion of non-Hodgkin's lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate(ORR) at 90 days
time frame: 90 days
description: The primary endpoint was ORR 90 days after IM19 infusion
arm group label: IM19 CAR-T cells
arm group type: Experimental
description: IM19 CAR-T cells be administrated in two dose level
intervention type: Drug
intervention name: IM19 CAR-T Cells
description: IM19 CAR-T cells
Drug: Fludarabine
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
Drug: Cyclophosphamide
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
arm group label: IM19 CAR-T cells
other name: Fludarabine
other name: Cyclophosphamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuqin Song, MD, PhD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Fei Wu, MD
phone: +8615801390058
email: wufei@immunochina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma, Non-Hodgkin
mesh term: Cyclophosphamide
mesh term: Fludarabine
sharing ipd: No