- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435720
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Cape Town, South Africa
- Unversity of Cape Town - Groote Schuur Hospital
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Pretoria, South Africa
- Pretoria East Hospital
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Arkansas
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Little Rock, Arkansas, United States, 72205
- The University of Arkansas for Medical Sciences
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Medical Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University Mary Babb Randolf Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1
0.0125 mg/kg
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0.05 mg/kg twice weekly x 6 weeks
0.2 mg/kg twice weekly x 6 weeks
0.375 mg/kg twice weekly x 6 weeks
0.0125 mg/kg twice weekly x 6 weeks
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Experimental: Cohort 2
0.05 mg/kg
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0.05 mg/kg twice weekly x 6 weeks
0.2 mg/kg twice weekly x 6 weeks
0.375 mg/kg twice weekly x 6 weeks
0.0125 mg/kg twice weekly x 6 weeks
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Experimental: Cohort 3
0.2 mg/kg
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0.05 mg/kg twice weekly x 6 weeks
0.2 mg/kg twice weekly x 6 weeks
0.375 mg/kg twice weekly x 6 weeks
0.0125 mg/kg twice weekly x 6 weeks
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Experimental: Cohort 4
0.375 mg/kg
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0.05 mg/kg twice weekly x 6 weeks
0.2 mg/kg twice weekly x 6 weeks
0.375 mg/kg twice weekly x 6 weeks
0.0125 mg/kg twice weekly x 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: Week 6
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Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of pharmacokinetics
Time Frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose
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Cmax, area under curve, Tmax.
Performed on Weeks 1, 3, 6, 10, 14, 18
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0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose
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Explore tumor response
Time Frame: Weeks 3 and 6, and monthly during a 24-week follow-up period
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IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma
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Weeks 3 and 6, and monthly during a 24-week follow-up period
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John A Lust, MD, PhD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Disease Attributes
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Recurrence
- Lymphoma, Mantle-Cell
- Leukemia, Plasma Cell
Other Study ID Numbers
- SNS01-T-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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