<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/NCT03281551</url>
  </required_header>
  <id_info>
    <org_study_id>PZ01</org_study_id>
    <nct_id>NCT03281551</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma</brief_title>
  <official_title>Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pinze Lifetechnology Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Navy General Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pinze Lifetechnology 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>
      The major aim of this research is to assess the feasibility, safety and effectiveness of CD19&#xD;
      CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma&#xD;
      patients who have applied it.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>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>Incidence of Treatment Related Adverse Events</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>2 months</time_frame>
    <description>Proportion of patients with reduction in tumor burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>6 months</time_frame>
    <description>Time from study enrollment until death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal residual disease negative remission rate(MRD)</measure>
    <time_frame>2 months</time_frame>
    <description>Proportion of MRD-negative patients.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>B-cell Acute Lymphoblastic Leukemia</condition>
  <condition>B-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>PZ01 CAR-T Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PZ01 CAR-T cells</intervention_name>
    <description>Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.</description>
    <arm_group_label>PZ01 CAR-T Cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects or their legal guardians participate in this experiment voluntarily and&#xD;
             informed consent form must be signed&#xD;
&#xD;
          2. In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for&#xD;
             Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology&#xD;
&#xD;
          3. In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the&#xD;
             following situations:&#xD;
&#xD;
               1. Getting through 2 treatments of standard chemotherapy with CR not yet obtained&#xD;
&#xD;
               2. Reach CR for the first inducement, but CR lasts for ≦12 months&#xD;
&#xD;
               3. r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated&#xD;
                  remedial treatment&#xD;
&#xD;
               4. ≧2 times of recurrence&#xD;
&#xD;
          4. Remedial chemotherapy is not used within 4 weeks before cell therapy&#xD;
&#xD;
          5. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but&#xD;
             not limited to systemic hormone therapy&#xD;
&#xD;
          6. Antibody drug treatment is not received within 2 weeks before cell therapy&#xD;
&#xD;
          7. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction&#xD;
             (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia&#xD;
&#xD;
          8. No pulmonary active infection is found, with normal pulmonary function and indoor air&#xD;
             SaO2 ≧92%&#xD;
&#xD;
          9. No contraindications for leukapheresis&#xD;
&#xD;
         10. Expected survival &gt;3 months&#xD;
&#xD;
         11. Grade 0 or 1 of ECOG performance status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and breastfeeding women&#xD;
&#xD;
          2. Uncontrolled active infection&#xD;
&#xD;
          3. Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A,&#xD;
             hepatitis B, hepatitis C and E.&#xD;
&#xD;
          4. Patients who have used a large amount of glucocorticoid or other immunosuppressive&#xD;
             drugs within 4 weeks&#xD;
&#xD;
          5. Stage II-IV Acute/chronic general graft versus host disease&#xD;
&#xD;
          6. Gene therapy has been undergone in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shengdian Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insitute of Biophysics,Chinese Academy of Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guoyan Wang</last_name>
    <phone>+86-018661838188</phone>
    <email>648818685@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Hematology, Navy General Hospital of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lixin Wang</last_name>
      <phone>86-013718000488</phone>
      <email>wgy@pinzelife.com</email>
    </contact>
    <investigator>
      <last_name>Jianliang Shen</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lixin Wang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</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>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_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/NCT03281551
org study id: PZ01
nct id: NCT03281551
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19
      CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma
      patients who have applied it.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment Related Adverse Events
time frame: 1 year
description: To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.
measure: Overall response rate (ORR)
time frame: 2 months
description: Proportion of patients with reduction in tumor burden.
measure: Overall survival (OS)
time frame: 6 months
description: Time from study enrollment until death.
measure: Minimal residual disease negative remission rate(MRD)
time frame: 2 months
description: Proportion of MRD-negative patients.
arm group label: PZ01 CAR-T Cells
arm group type: Experimental
description: This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.
intervention type: Drug
intervention name: PZ01 CAR-T cells
description: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
arm group label: PZ01 CAR-T Cells
criteria: 
gender: All
minimum age: 14 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shengdian Wang
role: Principal Investigator
affiliation: Insitute of Biophysics,Chinese Academy of Sciences
last name: Guoyan Wang
phone: +86-018661838188
email: 648818685@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Lymphoma, B-Cell
sharing ipd: No