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NCT03778073 Clinical Trial

Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

B-cell Non Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03778073
Other study ID # TG-1501-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date April 17, 2019
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date August 1, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cosibelimab
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 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.
• 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.

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Charlotte North Carolina
United States TG Therapeutics Investigational Trial Site Fairway Kansas
United States TG Therapeutics Investigational Trial Site Fayetteville Arkansas
United States TG Therapeutics Investigational Trial Site Fort Wayne Indiana
United States TG Therapeutics Investigational Trial Site Huntsville Alabama
United States TG Therapeutics Investigational Trial Site Louisville Kentucky
United States TG Therapeutics Investigational Trial Site Peoria Illinois
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months of therapy
Secondary Overall Response Rate Objective response in subjects treated with interventions Up to 12 months
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