<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/NCT02206308</url>
  </required_header>
  <id_info>
    <org_study_id>SCT400NHLI</org_study_id>
    <nct_id>NCT02206308</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.</brief_title>
  <official_title>A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinocelltech Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether SCT400 is safe and effective in the&#xD;
      treatment of B-cell Non Hodgkin's lymphoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Number of participants with infusion-related reaction and with drug-related adverse events.</measure>
    <time_frame>up to 27 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the plasma concentration versus time curve (AUC) of SCT400</measure>
    <time_frame>prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to disease progression</measure>
    <time_frame>up to 27 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>B-cell Non Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Chimeric anti-CD20 monoclonal antibody</intervention_name>
    <arm_group_label>single arm</arm_group_label>
    <other_name>SCT400</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged from 18 to 75 years&#xD;
&#xD;
          -  having histologically confirmed NHL expressing CD20 antigen&#xD;
&#xD;
          -  having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of&#xD;
             standard therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO&#xD;
             scale, and expected survival of at least ≥ 3 months&#xD;
&#xD;
          -  signed an informed consent form which was approved by the institutional review board&#xD;
             of the respective medical center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  single measurable lesion ≥7 cm in diameter&#xD;
&#xD;
          -  with serious hematologic dysfunction (white blood cell count of &lt;3.0×103/μL; absolute&#xD;
             neutrophil count of &lt;1.5×103/ μL; platelet count of &lt; 75×103/μL; hemoglobin level of &lt;&#xD;
             8.0 g/dL; serum immunoglobulin G(IgG) level of &lt;600 mg/dL);, hepatic dysfunction&#xD;
             (total bilirubin level of &gt; 1.5×upper limit of normal（ULN）; aspartate amino&#xD;
             transferase (AST) and alanine amino transferase (ALT) levels of &gt;2.5 × ULN (≥5 × ULN&#xD;
             for patients with liver metastases)); and renal dysfunction (serum creatinine level of&#xD;
             &gt; 1.5×ULN )&#xD;
&#xD;
          -  having to be at least 4 weeks beyond prior anticancer therapy including&#xD;
             corticosteroid, or participating in other clinical trial or have not recovered from&#xD;
             significant toxicities of prior therapy&#xD;
&#xD;
          -  had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1&#xD;
             year before enrollment&#xD;
&#xD;
          -  had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry&#xD;
&#xD;
          -  with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related&#xD;
             lymphoma; or active opportunistic infection, a serious nonmalignant disease&#xD;
&#xD;
          -  having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or&#xD;
             human immunodeficiency virus&#xD;
&#xD;
          -  with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis&#xD;
             syndrome; or recent major surgery (within 28 days )&#xD;
&#xD;
          -  with a history of allergic reaction or protein product allergy including murine&#xD;
             proteins&#xD;
&#xD;
          -  pregnant or lactating or not accepted birth control methods including male patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan kai Shi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China</affiliation>
  </overall_official>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chimeric anti-CD20 monoclonal antibody(SCT400)</keyword>
  <keyword>escalating doses</keyword>
  <keyword>safety</keyword>
  <keyword>pharmacokinetics and pharmacodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_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/NCT02206308
org study id: SCT400NHLI
nct id: NCT02206308
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether SCT400 is safe and effective in the
      treatment of B-cell Non Hodgkin's lymphoma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with infusion-related reaction and with drug-related adverse events.
time frame: up to 27 weeks
measure: Area Under the plasma concentration versus time curve (AUC) of SCT400
time frame: prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
measure: Time to disease progression
time frame: up to 27 weeks
arm group label: single arm
arm group type: Experimental
description: Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;
intervention type: Biological
intervention name: Chimeric anti-CD20 monoclonal antibody
arm group label: single arm
other name: SCT400
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yuan kai Shi, PhD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Antibodies
mesh term: Antibodies, Monoclonal