The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
It is a bispecific, first-in-class, CD47 and CD19 antibody
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States
TG Therapeutics Investigational Trial Site
Chattanooga, Tennessee, United States
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States
TG Therapeutics Investigational Trial Site
Houston, Texas, United States
RP2D
To determine the recommended Phase 2 dose (RP2D)
Time frame: Up to 24 months
Overall Response Rate
To evaluate the overall response rate (ORR) of TG-1801
Time frame: Up to 24 months
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