<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/NCT03778073</url>
  </required_header>
  <id_info>
    <org_study_id>TG-1501-101</org_study_id>
    <nct_id>NCT03778073</nct_id>
  </id_info>
  <brief_title>Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma</brief_title>
  <official_title>A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TG Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TG Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or&#xD;
      refractory B-cell Non Hodgkin's Lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent&#xD;
      cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic/Business Decision&#xD;
  </why_stopped>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 3, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events That Are Related to Treatment</measure>
    <time_frame>6 months of therapy</time_frame>
    <description>Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Objective response in subjects treated with interventions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>B-cell Non Hodgkin Lymphoma</condition>
  <condition>Richter's Transformation</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cosibelimab (TG-1501) single-agent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cosibelimab + Ublituximab + Bendamustine combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cosibelimab + Ublituximab + Bendamustine combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cosibelimab</intervention_name>
    <description>Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle</description>
    <arm_group_label>Cohort A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cosibelimab + Ublituximab + Bendamustine combination</intervention_name>
    <description>Cosibelimab (Intravenous infusion):&#xD;
Cycle 1-6 Days 1&amp;15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;&#xD;
Ublituximab (Intravenous infusion):&#xD;
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;&#xD;
Bendamustine (Intravenous infusion):&#xD;
Cycle 1 Days 2&amp;3, Cycles 2-6 Days 1&amp;2.</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cosibelimab + Ublituximab + Bendamustine combination</intervention_name>
    <description>Cosibelimab (Intravenous infusion):&#xD;
Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;&#xD;
Ublituximab (Intravenous infusion):&#xD;
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;&#xD;
Bendamustine (Intravenous infusion):&#xD;
Cycle 1 Days 2&amp;3, Cycles 2-6 Days 1&amp;2.</description>
    <arm_group_label>Cohort C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).&#xD;
&#xD;
          -  Measurable disease and adequate organ function as specified in the protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with&#xD;
             bendamustine.&#xD;
&#xD;
          -  Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1&#xD;
             Day 1.&#xD;
&#xD;
          -  Prior autologous stem cell transplant within 3 months&#xD;
&#xD;
          -  Active Hepatitis B or Hepatitis C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>relapsed or refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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>Bendamustine Hydrochloride</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/NCT03778073
org study id: TG-1501-101
nct id: NCT03778073
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or
      refractory B-cell Non Hodgkin's Lymphoma.
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent
      cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events That Are Related to Treatment
time frame: 6 months of therapy
description: Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
measure: Overall Response Rate
time frame: Up to 12 months
description: Objective response in subjects treated with interventions
arm group label: Cohort A
arm group type: Experimental
description: Cosibelimab (TG-1501) single-agent
arm group label: Cohort B
arm group type: Experimental
description: Cosibelimab + Ublituximab + Bendamustine combination
arm group label: Cohort C
arm group type: Experimental
description: Cosibelimab + Ublituximab + Bendamustine combination
intervention type: Drug
intervention name: Cosibelimab
description: Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
arm group label: Cohort A
intervention type: Drug
intervention name: Cosibelimab + Ublituximab + Bendamustine combination
description: Cosibelimab (Intravenous infusion):
Cycle 1-6 Days 1&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
Ublituximab (Intravenous infusion):
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
Bendamustine (Intravenous infusion):
Cycle 1 Days 2&3, Cycles 2-6 Days 1&2.
arm group label: Cohort B
intervention type: Drug
intervention name: Cosibelimab + Ublituximab + Bendamustine combination
description: Cosibelimab (Intravenous infusion):
Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
Ublituximab (Intravenous infusion):
Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
Bendamustine (Intravenous infusion):
Cycle 1 Days 2&3, Cycles 2-6 Days 1&2.
arm group label: Cohort C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Bendamustine Hydrochloride
mesh term: Antibodies, Monoclonal