<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/NCT03262298</url>
  </required_header>
  <id_info>
    <org_study_id>307-B-22-CAR-T</org_study_id>
    <nct_id>NCT03262298</nct_id>
  </id_info>
  <brief_title>Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies</brief_title>
  <official_title>Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital to Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital to Academy of Military Medical Sciences</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>
      The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor&#xD;
      modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has&#xD;
      been accompanied by the associated finding that antigen-escape variants of the disease are&#xD;
      responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce&#xD;
      remissions for many patients with relapsed and refractory B cell malignancies, a part of&#xD;
      those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane&#xD;
      protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a&#xD;
      significant role in signal transduction pathway. The investigators design and conduct this&#xD;
      trial to test the safety and effectiveness of CD22-targeted CAR-T.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">August 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2021</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>Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Complete Remission Rate (ORR)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease response(CR, CRi)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CART cells persistence in vivo</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Leukemia</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>anti-CD22 CAR-T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a full dose CART infusion at day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anti-CD22-CAR-transduced T cells</intervention_name>
    <description>a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.</description>
    <arm_group_label>anti-CD22 CAR-T</arm_group_label>
    <other_name>anti-CD22 CART, CART22</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18-65 years&#xD;
&#xD;
          2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as&#xD;
             confirmed by flow cytometry&#xD;
&#xD;
          3. Refractory or relapsed B cell-acute lymphoblastic leukemia&#xD;
&#xD;
          4. No available curative treatment options (such as hematopoietic stem cell&#xD;
             transplantation)&#xD;
&#xD;
          5. Stage III-IV disease&#xD;
&#xD;
          6. Creatinine &lt; 2.5 mg/dl&#xD;
&#xD;
          7. Aspartate transaminase-alanine transaminase ratio &lt; 3x normal&#xD;
&#xD;
          8. Bilirubin &lt; 2.0 mg/dl&#xD;
&#xD;
          9. Karnofsky performance status &gt;= 60&#xD;
&#xD;
         10. Expected survival time &gt; 3 months&#xD;
&#xD;
         11. Adequate venous access for apheresis&#xD;
&#xD;
         12. Ability to understand and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women&#xD;
&#xD;
          2. Patients requiring T cell immunosuppressive therapy&#xD;
&#xD;
          3. Active central nervous system leukemia&#xD;
&#xD;
          4. Any concurrent active malignancies&#xD;
&#xD;
          5. Patients with a history of a seizure disorder or cardiac disorder&#xD;
&#xD;
          6. Previous treatment with any immunotherapy products&#xD;
&#xD;
          7. Patients with human immunodeficiency virus, hepatitis B or C infection&#xD;
&#xD;
          8. Uncontrolled active infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liangding Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital to Academy of Military Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liangding Hu, M.D.</last_name>
    <phone>+86-010-6694-7107</phone>
    <email>huliangding@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fengtai District</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>+8618501002450</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 6, 2021</last_update_submitted>
  <last_update_submitted_qc>February 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CD22</keyword>
  <keyword>CAR-T</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03262298
org study id: 307-B-22-CAR-T
nct id: NCT03262298
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor
      modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.
Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has
      been accompanied by the associated finding that antigen-escape variants of the disease are
      responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce
      remissions for many patients with relapsed and refractory B cell malignancies, a part of
      those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane
      protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a
      significant role in signal transduction pathway. The investigators design and conduct this
      trial to test the safety and effectiveness of CD22-targeted CAR-T.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
time frame: 2 years
measure: Overall Complete Remission Rate (ORR)
time frame: 2 years
measure: Disease response(CR, CRi)
time frame: 2 years
measure: CART cells persistence in vivo
time frame: 2 years
arm group label: anti-CD22 CAR-T
arm group type: Experimental
description: Patients will receive a full dose CART infusion at day 0.
intervention type: Biological
intervention name: Anti-CD22-CAR-transduced T cells
description: a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
arm group label: anti-CD22 CAR-T
other name: anti-CD22 CART, CART22
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Liangding Chen, M.D.
role: Principal Investigator
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
last name: Liangding Hu, M.D.
phone: +86-010-6694-7107
email: huliangding@sohu.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
sharing ipd: Undecided