xml: <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/NCT05970822</url>
    </required_header>
    <id_info>
      <org_study_id>BC3402-104</org_study_id>
      <nct_id>NCT05970822</nct_id>
    </id_info>
    <brief_title>Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML</brief_title>
    <official_title>A Phase 1b Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of BC3402 in Combination With Azacitidine in Subjects With Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biocity Biopharmaceutics Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biocity Biopharmaceutics Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</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 is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in&#xD;
        combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and&#xD;
        Chronic myelomonocytic leukemia (CMML)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 18, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</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 patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)</measure>
      <time_frame>2.5 years</time_frame>
      <description>To evaluate the safety and tolerability of BC3402</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Myelodysplastic Syndromes</condition>
    <condition>Chronic Myelomonocytic Leukemia</condition>
    <arm_group>
      <arm_group_label>BC3402+azacitidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive azacitidine and BC3402 in a treatment cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BC3402</intervention_name>
      <description>Escalating of BC3402 will be administered IV(intravenous)</description>
      <arm_group_label>BC3402+azacitidine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Azacitidine</intervention_name>
      <description>Azacitidine will be administered daily</description>
      <arm_group_label>BC3402+azacitidine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. MDS and CMML subjects with higher risk;&#xD;
  &#xD;
            2. Age ≥ 18 years old;&#xD;
  &#xD;
            3. Eastern Cooperative Oncology Group score of 0~2;&#xD;
  &#xD;
            4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);&#xD;
  &#xD;
            5. Subjects should take effective contraceptive measures&#xD;
  &#xD;
            6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior exposure to anti-TIM-3 therapy at any time&#xD;
  &#xD;
            2. Previous HSCT&#xD;
  &#xD;
            3. Live vaccine administered within 4 weeks prior to start of treatment&#xD;
  &#xD;
            4. Current use or use within 7 days prior to start of treatment of systemic steroid&#xD;
               therapy (&gt; 10 mg/day prednisone or equivalent) or any immunosuppressive therapy.&#xD;
               Topical, inhaled, nasal, ophthalmic steroids are allowed.&#xD;
  &#xD;
          Other protocol-defined Inclusion/Exclusion may apply.&#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>Zhijian Xiao, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zijian Xiao, MD</last_name>
      <phone>+86 13821085716</phone>
      <email>zjxiao@ihcams.ac.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bing Li, MD</last_name>
      <phone>+86 15522279160</phone>
      <email>libing@ihcams.ac.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhijian Xiao, MD</last_name>
        <phone>+86 13821085716</phone>
        <email>zjxiao@ihcams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Leukemia</mesh_term>
      <mesh_term>Preleukemia</mesh_term>
      <mesh_term>Leukemia, Myelomonocytic, Chronic</mesh_term>
      <mesh_term>Leukemia, Myelomonocytic, Juvenile</mesh_term>
      <mesh_term>Myelodysplastic Syndromes</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Azacitidine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970822
  org study id: BC3402-104
  nct id: NCT05970822
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in
        combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and
        Chronic myelomonocytic leukemia (CMML)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
  time frame: 2.5 years
  description: To evaluate the safety and tolerability of BC3402
  arm group label: BC3402+azacitidine
  arm group type: Experimental
  description: Subjects will receive azacitidine and BC3402 in a treatment cycle.
  intervention type: Drug
  intervention name: BC3402
  description: Escalating of BC3402 will be administered IV(intravenous)
  arm group label: BC3402+azacitidine
  intervention type: Drug
  intervention name: Azacitidine
  description: Azacitidine will be administered daily
  arm group label: BC3402+azacitidine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhijian Xiao, MD
  role: Principal Investigator
  affiliation: Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
  last name: Zijian Xiao, MD
  phone: +86 13821085716
  email: zjxiao@ihcams.ac.cn
  last name: Bing Li, MD
  phone: +86 15522279160
  email: libing@ihcams.ac.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Preleukemia
  mesh term: Leukemia, Myelomonocytic, Chronic
  mesh term: Leukemia, Myelomonocytic, Juvenile
  mesh term: Myelodysplastic Syndromes
  mesh term: Azacitidine