drugset / Trial / NCT00983619

A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies

NCT00983619

Phase 1/2 Completed 136 enrolled MedImmune LLC
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

Timeline

Start
2010-04-16
Primary completion
2019-03-21
Completion
2019-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Inebilizumab Monoclonal antibody 0.5 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 1 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 4 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 6 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 8 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 12 mg/kg Intravenous
Subject Inebilizumab Monoclonal antibody 24 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications