<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/NCT03824964</url>
  </required_header>
  <id_info>
    <org_study_id>CD19/CD22 CAR NK-BJZL-01</org_study_id>
    <nct_id>NCT03824964</nct_id>
  </id_info>
  <brief_title>Study of Anti-CD19/CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma</brief_title>
  <official_title>An Observational Clinical Study on the Safety and Efficacy of Anti-CD19/CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allife Medical Science and Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allife Medical Science and Technology Co., Ltd.</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>
      This is a single-centre, single-arm and open-label study to investigate the safety and&#xD;
      efficacy of anti CD19/CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of treatment related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as &gt;= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.</description>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Refractory B-Cell Lymphoma</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anti-CD19/CD22 CAR NK Cells</intervention_name>
    <description>Total dose of 50-600 thousand /kg Anti-CD19/CD22 CAR NK cells will be administered at day0</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. CD19(+) CD22(+) B cell lymphoma confirmed by pathological immunohistochemistry or flow&#xD;
             cytometry&#xD;
&#xD;
          2. Previously accepted ≥ first-line regimen chemotherapy&#xD;
&#xD;
          3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence&#xD;
             after hematopoietic stem cell transplantation&#xD;
&#xD;
          4. Over 18 years old and under 70 years old&#xD;
&#xD;
          5. The expected survival period is more than 3 months.&#xD;
&#xD;
          6. ECOG≤2&#xD;
&#xD;
          7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection&#xD;
             fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine&#xD;
             clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;&#xD;
&#xD;
          8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;&#xD;
&#xD;
          9. The pregnancy test for women of childbearing age must be negative; both men and women&#xD;
             must agree to use effective contraception during the treatment period and for the&#xD;
             following 1 year.&#xD;
&#xD;
         10. Measurable target lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with extramedullary relapse&#xD;
&#xD;
          2. Burkitt's lymphoma/leukemia&#xD;
&#xD;
          3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any&#xD;
             anti-CD19/CD22 treatment;&#xD;
&#xD;
          4. Liver and kidney function:&#xD;
&#xD;
               -  Total bilirubin &gt; 2 x ULN (Gilbert Syndrome &gt; 3 x ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &gt; 3 × ULN&#xD;
&#xD;
               -  Serum creatinine clearance &gt;60 mL/min&#xD;
&#xD;
          5. Serological examination:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &lt;0.75x109/L&#xD;
&#xD;
               -  Platelet count (PLT) &lt;50x109/L&#xD;
&#xD;
          6. Active hepatitis B (HBV-DNA &gt; 1000 copies / mL), hepatitis C, or uncontrolled&#xD;
             infection&#xD;
&#xD;
          7. GVHD ≥ 2 or anti-GVHD treatment&#xD;
&#xD;
          8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion,&#xD;
             such as donor lymphocyte infusion;&#xD;
&#xD;
          9. Subject received the most recent treatment (release, chemotherapy, or other) less than&#xD;
             4 weeks&#xD;
&#xD;
         10. Active CNS disease (tumor cells in CSF, but &lt; 5 WBCs/mL can be included);&#xD;
&#xD;
         11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular&#xD;
             internal coagulation&#xD;
&#xD;
         12. Creatinine &gt; 1.5 times normal upper limit or ALT / AST &gt; 3 times normal upper limit or&#xD;
             bilirubin &gt; 2 times normal upper limit&#xD;
&#xD;
         13. New York Heart Association (NYHA) graded above or above&#xD;
&#xD;
         14. Uncontrollable diabetes&#xD;
&#xD;
         15. Suffering from other uncontrolled diseases, the researchers believe that it is not&#xD;
             suitable for joining&#xD;
&#xD;
         16. Any situation that the investigator believes may increase the risk of the subject or&#xD;
             interfere with the test results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</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</mesh_term>
    <mesh_term>Lymphoma, 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/NCT03824964
org study id: CD19/CD22 CAR NK-BJZL-01
nct id: NCT03824964
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a single-centre, single-arm and open-label study to investigate the safety and
      efficacy of anti CD19/CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of treatment related adverse events as assessed by CTCAE v4.0
time frame: 1 year
description: Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
intervention type: Biological
intervention name: Anti-CD19/CD22 CAR NK Cells
description: Total dose of 50-600 thousand /kg Anti-CD19/CD22 CAR NK cells will be administered at day0
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell