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Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778073
Recruitment Status : Terminated (Strategic/Business Decision)
First Posted : December 19, 2018
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief Summary:
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Non Hodgkin Lymphoma Richter's Transformation Drug: Cosibelimab Drug: Cosibelimab + Ublituximab + Bendamustine combination Phase 1

Detailed Description:
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
Actual Study Start Date : April 17, 2019
Actual Primary Completion Date : May 3, 2022
Actual Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A
Cosibelimab (TG-1501) single-agent
 Drug: Cosibelimab
Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
Experimental: Cohort B
Cosibelimab + Ublituximab + Bendamustine combination
 Drug: Cosibelimab + Ublituximab + Bendamustine combination

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.
Experimental: Cohort C
Cosibelimab + Ublituximab + Bendamustine combination
 Drug: Cosibelimab + Ublituximab + Bendamustine combination

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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 12 months ]
    Objective response in subjects treated with interventions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
  • Measurable disease and adequate organ function as specified in the protocol

Key Exclusion Criteria:

  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
  • Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
  • Prior autologous stem cell transplant within 3 months
  • Active Hepatitis B or Hepatitis C
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778073


Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States, 85711
United States, Arkansas
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States, 72703
United States, Illinois
TG Therapeutics Investigational Trial Site
Peoria, Illinois, United States, 61615
United States, Indiana
TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana, United States, 46804
United States, Kansas
TG Therapeutics Investigational Trial Site
Fairway, Kansas, United States, 64154
United States, Kentucky
TG Therapeutics Investigational Trial Site
Louisville, Kentucky, United States, 40207
United States, North Carolina
TG Therapeutics Investigational Trial Site
Charlotte, North Carolina, United States, 28262
United States, Washington
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States, 98108
Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03778073    
Other Study ID Numbers: TG-1501-101
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TG Therapeutics, Inc.:
relapsed or refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
 Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs