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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.
Full description
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.
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Inclusion criteria
B cell lymphoma patients must have had their diagnosis confirmed histologically. Plasma cell leukemia (PCL) patients must have peripheral clonal plasma cells >20% of peripheral WBC and >2 x 109/L. Multiple myeloma and PCL patients must have been diagnosed by having met all three of the following IMWG criteria:
Clonal bone marrow plasma cells >10%
Presence of serum and/or urinary M-protein or, if absent, kappa or lambda serum FLC must be > 10 mg/dl accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65)
Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:
B cell lymphoma patients must have measurable disease defined as at least one lesion that can be accurately measured for response in at least two perpendicular dimensions. Multiple myeloma patients must have measurable disease defined by the following:
Have relapsed or refractory disease after two or more prior treatment lines, each of which may have consisted of either single or multiple regimens. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.
Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Have life expectancy of at least 3 months
Be ≥18 years of age and willing to provide written informed consent
For women and men of childbearing potential, have used effective contraceptive methods for at least 4 weeks prior to dosing and agree to continue using such methods during the study, and for at least 4 weeks after completing the study
For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy
Have an absolute neutrophil count >1,000/mm3
Have a platelet count >75,000/mm3
Have total bilirubin <2.0 mg/dL
Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal
Have serum creatinine ≤3 times the upper limit of normal
Have hemoglobin ≥8.0 g/dL
Exclusion criteria
Primary purpose
Allocation
Interventional model
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15 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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