Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    TG1501
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778073
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 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
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2024


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.





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: TG Therapeutics Clinical Support Team 1-877-555-8489 clinicalsupport@tgtxinc.com

Locations
Layout table for location information
United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site Recruiting
Tucson, Arizona, United States, 85711
United States, Arkansas
TG Therapeutics Investigational Trial Site Recruiting
Fayetteville, Arkansas, United States, 72703
United States, Illinois
TG Therapeutics Investigational Trial Site Recruiting
Peoria, Illinois, United States, 61615
United States, Indiana
TG Therapeutics Investigational Trial Site Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Kansas
TG Therapeutics Investigational Trial Site Recruiting
Fairway, Kansas, United States, 64154
United States, Kentucky
TG Therapeutics Investigational Trial Site Recruiting
Louisville, Kentucky, United States, 40207
United States, North Carolina
TG Therapeutics Investigational Trial Site Recruiting
Charlotte, North Carolina, United States, 28262
Contact: clinicalsupport@tgtxinc.com         
United States, Washington
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
TG Therapeutics, Inc.
Layout table for additonal information
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: November 19, 2021
Last Verified: November 2021

Layout table for additional information
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:
Layout table for MeSH terms
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