Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

August 19, 2022 updated by: TG Therapeutics, Inc.

A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Tucson, Arizona, United States, 85711
        • TG Therapeutics Investigational Trial Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • TG Therapeutics Investigational Trial Site
    • Kansas
      • Fairway, Kansas, United States, 64154
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Seattle, Washington, United States, 98108
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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.
Experimental: Cohort C
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 12 months
Objective response in subjects treated with interventions
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-1501-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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