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/NCT05994157</url>
    </required_header>
    <id_info>
      <org_study_id>1201</org_study_id>
      <nct_id>NCT05994157</nct_id>
    </id_info>
    <brief_title>Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma</brief_title>
    <official_title>Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Y-mAbs Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Y-mAbs Therapeutics</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP&#xD;
        is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and&#xD;
        177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA,&#xD;
        and 177Lu-DOTA.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)</measure>
      <time_frame>4 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)</measure>
      <time_frame>4 weeks</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Non-hodgkin Lymphoma</condition>
    <arm_group>
      <arm_group_label>CD38-SADA:177Lu-DOTA Complex</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CD38-SADA:177Lu-DOTA Complex</intervention_name>
      <description>The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.</description>
      <arm_group_label>CD38-SADA:177Lu-DOTA Complex</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Target population must have relapsed, progressive or refractory non-hodgkin lymphoma&#xD;
               and be ineligible for or have exhausted standard therapeutic options that may prolong&#xD;
               survival&#xD;
  &#xD;
            -  The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease&#xD;
  &#xD;
            -  CD38 positive tumor at most recent biopsy (new or archival) documented at central&#xD;
               laboratory&#xD;
  &#xD;
            -  Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
               score of 0, 1, or 2&#xD;
  &#xD;
            -  Each subject must sign an ICF indicating that he or she understands the purpose of,&#xD;
               and procedures required for the trial and is willing to participate in the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Primary central nervous system lymphoma or known central nervous system involvement&#xD;
               with lymphoma&#xD;
  &#xD;
            -  Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered&#xD;
               within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA&#xD;
  &#xD;
            -  Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA&#xD;
  &#xD;
            -  Autologous stem cell transplantation within 42 days prior to the first dose of&#xD;
               CD38-SADA&#xD;
  &#xD;
            -  Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA&#xD;
  &#xD;
            -  &gt;40% lymphoma bone marrow involvement&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    </condition_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/NCT05994157
  org study id: 1201
  nct id: NCT05994157
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP
        is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and
        177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA,
        and 177Lu-DOTA.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
  time frame: 4 weeks
  measure: Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
  time frame: 4 weeks
  arm group label: CD38-SADA:177Lu-DOTA Complex
  arm group type: Experimental
  intervention type: Drug
  intervention name: CD38-SADA:177Lu-DOTA Complex
  description: The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.
  arm group label: CD38-SADA:177Lu-DOTA Complex
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Non-Hodgkin