Status:
TERMINATED
Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
B-cell Non Hodgkin Lymphoma
Richter's Transformation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- Measurable disease and adequate organ function as specified in the protocol
- Key
Exclusion
- 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
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03778073
Start Date
April 17 2019
End Date
August 1 2022
Last Update
August 22 2022
Active Locations (9)
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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