This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Incidence of adverse events
Time frame: Through 1 month post last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month post last dose
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Time frame: Through up to approximately 6 week post last dose
Duration of response
Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Time frame: Until death or study closure, an expected average of 1 year
Blood concentration of SGN-CD19A and metabolites
Time frame: Through up to approximately 6 weeks post last dose
Incidence of antitherapeutic antibodies
Time frame: Through up to approximately 6 weeks post last dose
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States