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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01435720
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:
Hypercalcemia: serum calcium >11.5 mg/100 mL
Renal insufficiency: serum creatinine >2mg/dL
Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL
Bone lesions: lytic lesions, severe osteopenia, or pathologic fractures
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:
Serum M-protein ≥0.5g/dL or urine M-protein ≥ 200 mg/24 hours by protein electrophoresis
If neither serum nor urine M-protein meet the criteria above, then kappa or lambda serum FLC must be ≥10 mg/dL accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65) (Serum FLC should only be used for patients without measurable serum or urine M-protein spike.)
If neither of the above criteria are met, the presence of plasmacytomata measurable radiographically (CT, PET or MRI) or by direct measurement.
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
Have presence of nonsecretory myeloma
Have an indolent lymphoma such as follicular lymphoma unless the disease is rapidly progressing
Requires renal dialysis
Have New York Heart Association Class III-IV heart failure classification
Have CNS or leptomeningeal disease
Have an active infection or serious comorbid medical condition
Be receiving other concurrent anticancer agents or therapies
Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening or 5 half-lives, if known, whichever is shorter
Be eligible to receive any other standard therapy available that is known to extend life expectancy
Be currently receiving steroids unless equivalent to 20 mg of prednisone or less
Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T
Be pregnant or nursing
All locations for NCT01435720
United States (5)
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Rochester, Minnesota, United States, 55905
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Fred Hutchinson Cancer Research Center/University of Washington Medical Center
Seattle, Washington, United States, 98109
West Virginia University Mary Babb Randolf Cancer Center
Morgantown, West Virginia, United States, 26506
South Africa (2)
Unversity of Cape Town - Groote Schuur Hospital
Cape Town, South Africa
Pretoria East Hospital
Pretoria, South Africa
View full eligibility
Tris trial is registered with FDA with number: NCT01435720. The sponsor of the trial is Senesco Technologies, Inc. and it is looking for 15 volunteers for the current phase.
Official trial title: Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies
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