Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03778073

Collaborator

(none)

Enrollment

Locations

Arms

39.5

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Apr 17, 2019

Actual Primary Completion Date :

May 3, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

Adverse Events That Are Related to Treatment [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

Overall Response Rate [Up to 12 months]
Objective response in subjects treated with interventions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Investigational Trial Site	Huntsville	Alabama	United States	35805
2	TG Therapeutics Investigational Trial Site	Tucson	Arizona	United States	85711
3	TG Therapeutics Investigational Trial Site	Fayetteville	Arkansas	United States	72703
4	TG Therapeutics Investigational Trial Site	Peoria	Illinois	United States	61615
5	TG Therapeutics Investigational Trial Site	Fort Wayne	Indiana	United States	46804
6	TG Therapeutics Investigational Trial Site	Fairway	Kansas	United States	64154
7	TG Therapeutics Investigational Trial Site	Louisville	Kentucky	United States	40207
8	TG Therapeutics Investigational Trial Site	Charlotte	North Carolina	United States	28262
9	TG Therapeutics Investigational Trial Site	Seattle	Washington	United States	98108

Sponsors and Collaborators

TG Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TG Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03778073

Other Study ID Numbers:

TG-1501-101

First Posted:

Dec 19, 2018

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by TG Therapeutics, Inc.

relapsed or refractory

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Bendamustine Hydrochloride

Antibodies, Monoclonal

Study Results

No Results Posted as of Aug 22, 2022