Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Phase 1

Terminated

• Conditions: B-cell Non Hodgkin Lymphoma; Richter's Transformation
• Interventions: Drug: Cosibelimab; Drug: Cosibelimab + Ublituximab + Bendamustine combination

• Registration Number: NCT03778073
• Lead Sponsor: TG Therapeutics, Inc.

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 Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2019-04-17
• Primary Completion: 2022-05-03
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Cosibelimab	Cosibelimab (TG-1501) single-agent
Cohort B	Cosibelimab + Ublituximab + Bendamustine combination	Cosibelimab + Ublituximab + Bendamustine combination
Cohort C	Cosibelimab + Ublituximab + Bendamustine combination	Cosibelimab + Ublituximab + Bendamustine combination

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Response Rate	Up to 12 months	Objective response in subjects treated with interventions

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Seattle, Washington, United States