NCT00354926

Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma

Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Applied Molecular Evolution · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.

Detailed description

The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	AME-133v (LY2469298)	IV 4X weekly X 4

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-07-20
• Last updated: 2016-01-07

Locations

11 sites across 1 country: United States