NCT03778073

Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-cell Non Hodgkin Lymphoma
• Richter's Transformation

Interventions

Type	Name	Description
DRUG	Cosibelimab	Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
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.

Timeline

• Start date: 2019-04-17
• Primary completion: 2022-05-03
• Completion: 2022-08-01
• First posted: 2018-12-19
• Last updated: 2022-08-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study