The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.
The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mayo Clinic
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Fred Hutchinson Cancer Research Center/University of Washington Medical Center
Seattle, Washington, United States
West Virginia University Mary Babb Randolf Cancer Center
Morgantown, West Virginia, United States
Unversity of Cape Town - Groote Schuur Hospital
Cape Town, South Africa
Pretoria East Hospital
Pretoria, South Africa
Safety and tolerability
Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values
Time frame: Week 6
Profile of pharmacokinetics
Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18
Time frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose
Explore tumor response
IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma
Time frame: Weeks 3 and 6, and monthly during a 24-week follow-up period
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