This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
IV 4X weekly X 4
University of Alabama Medical Center
Birmingham, Alabama, United States
UCLA Medical Hematology and Oncology
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Adverse Events
Time frame: Until the patient is off study (an average of 10 months)
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Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
...and 1 more locations