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Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Primary Purpose

B-cell Non Hodgkin Lymphoma, Richter's Transformation

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cosibelimab
Cosibelimab + Ublituximab + Bendamustine combination
Cosibelimab + Ublituximab + Bendamustine combination
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Non Hodgkin Lymphoma focused on measuring relapsed or refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Cosibelimab (TG-1501) single-agent

Cosibelimab + Ublituximab + Bendamustine combination

Cosibelimab + Ublituximab + Bendamustine combination

Outcomes

Primary Outcome Measures

Adverse Events That Are Related to Treatment
Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Overall Response Rate
Objective response in subjects treated with interventions

Full Information

First Posted
December 11, 2018
Last Updated
August 19, 2022
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03778073
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business Decision
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non Hodgkin Lymphoma, Richter's Transformation
Keywords
relapsed or refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Cosibelimab (TG-1501) single-agent
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Cosibelimab + Ublituximab + Bendamustine combination
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Cosibelimab + Ublituximab + Bendamustine combination
Intervention Type
Drug
Intervention Name(s)
Cosibelimab
Intervention Description
Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Cosibelimab + Ublituximab + Bendamustine combination
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Cosibelimab + Ublituximab + Bendamustine combination
Intervention 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.
Primary Outcome Measure Information:
Title
Adverse Events That Are Related to Treatment
Description
Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
Time Frame
6 months of therapy
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Objective response in subjects treated with interventions
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
64154
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

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