Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

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Brief Title

Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Official Title

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

Brief Summary

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

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Adverse Events That Are Related to Treatment

Secondary Outcome

 Overall Response Rate

Condition

B-cell Non Hodgkin Lymphoma

Intervention

Cosibelimab

Study Arms / Comparison Groups

 Cohort A
Description:  Cosibelimab (TG-1501) single-agent

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

72

Start Date

April 17, 2019

Completion Date

August 2024

Primary Completion Date

August 2022

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 1-877-555-8489, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03778073

Organization ID

TG-1501-101


Responsible Party

Sponsor

Study Sponsor

TG Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

January 2022