Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Phase 1TerminatedNCT03778073

TG Therapeutics, Inc.18 enrolled

Overview

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

This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

B-cell Non Hodgkin Lymphoma Richter's Transformation

Interventions

CosibelimabDRUG

Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle

Cosibelimab + Ublituximab + Bendamustine combinationDRUG

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.

Cosibelimab + Ublituximab + Bendamustine combinationDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Tucson, Arizona, United States

TG Therapeutics Investigational Trial Site

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months of therapy

Secondary Outcomes

Overall Response Rate

Objective response in subjects treated with interventions

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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