Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

Summary

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.

Timeline

Start

2010-09

Primary completion

2013-01

Completion

2013-01

Publications

• Woyach JA, Awan F, Flinn IW, Berdeja JG, Wiley E, Mansoor S, Huang Y, Lozanski G, Foster PA, Byrd JC. A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. Blood. 2014 Dec 4;124(24):3553-60. doi: 10.1182/blood-2014-08-593269. Epub 2014 Oct 9.

Drugs

Indications