A Phase I Trial Of Ublituximab (Tg-1101), A Novel Glycoengineered Anti-Cd20 Monoclonal Antibody (Mab) In B-Cell Non-Hodgkin Lymphoma Patients With Prior Exposure To Rituximab.

8524 Background: Ublituximab (UTX) is a novel mAb targeting a unique epitope on the CD20 antigen, glycoengineered for greater ADCC than rituximab (RTX). A prior Phase I/Ib trial with UTX monotherapy in patients (pts) with relapsed/refractory (R/R) CLL reported an ORR of 45%. Herein we report the results of a Phase I/Ib trial of UTX in pts with RTX R/R B-cell lymphoma (BCL). Methods: Eligible pts have R/R BCL that was previously treated with RTX containing regimens, with ECOG PS u003c 3. 3+3 dose-escalation evaluated cohorts of 450, 600, 900, and 1200 mg. Select expansion cohorts have included R/R NHL and CLL pts. UTX is administered weekly x 4 doses in Cycle 1 for NHL pts and on days 1, 8, 15 in Cycles 1 u0026 2 for CLL pts (cycle = 28 days), with maintenance for all pts. Primary endpoints: Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLT). Secondary endpoints: PK/PD and Efficacy. Results: 32 pts were enrolled. 17 M/15 F with: Median age 68 yr (range 45-88); ECOG 0/1/2: 12/18/2; Median prior Tx = 3 ...