<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/NCT04453397</url>
  </required_header>
  <id_info>
    <org_study_id>TNB383B.9001</org_study_id>
    <nct_id>NCT04453397</nct_id>
  </id_info>
  <brief_title>Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma</brief_title>
  <official_title>A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TeneoOne Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TeneoOne Inc.</source>
  <brief_summary>
    <textblock>
      This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple&#xD;
      myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit&#xD;
      in MM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Multiple Myeloma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TNB-383B</intervention_name>
    <description>TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adequate bone marrow function&#xD;
&#xD;
          -  eGFR ≥ 30 mL/min&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 × upper limit of normal (ULN)&#xD;
&#xD;
          -  Serum calcium (corrected for albumin) at or below the ULN range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Candidate for treatment regimens known to provide clinical benefit in MM&#xD;
&#xD;
          -  Active infection requiring parenteral anti-infective treatment&#xD;
&#xD;
          -  Any medical or psychiatric condition which in the opinion of the investigator or&#xD;
             Teneobio Medical Monitor places the subject at an unacceptably high risk for&#xD;
             toxicities, could interfere with successful or safe delivery of therapy, or could&#xD;
             interfere with evaluation of the investigational product or interpretation of subject&#xD;
             safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ben Buelow</last_name>
    <role>Study Chair</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</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>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma 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/NCT04453397
org study id: TNB383B.9001
nct id: NCT04453397
lead sponsor: 
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple
      myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit
      in MM.
expanded access type individual: Yes
intervention type: Drug
intervention name: TNB-383B
description: TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Ben Buelow
role: Study Chair
affiliation: Amgen
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell