The study will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.
SGN-CD19B will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days). Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Given intravenously Day 1 of 28-day or 42-day cycles
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University (NYU) Cancer Institute
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 6 more locations
Incidence of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
Blood concentrations of SGN-CD19B
Time frame: Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose
Objective response rate
Time frame: Through 1 month following last dose
Rate of response
Time frame: Through 1 month following last dose
Progression-free survival
Time frame: Up to approximately 3 years
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