This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell Non-Hodgkin's Lymphoma (NHL). TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data observed to date support its safety in patients with autoimmune disorders. Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects with relapsed NHL (see inclusion criteria for subtypes). Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks
Unnamed facility
Duarte, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Buffalo, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Safety: physical examinations, laboratory tests, adverse events. Maximum Tolerated Dose: dose-limiting toxicities. Efficacy: disease response and progression status per International Response Criteria for NHL.
Time frame: 9 months
Objective response rate in subjects with relapsed follicular NHL.
Time frame: 2 years
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