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Complete title: A 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 Multiple Myeloma, Mantle Cell Lymphoma or Diffuse Large B Cell Lymphoma
|Research Study Number||2669.00|
|Principal Investigator||Bill Bensinger, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 1. MCL and DLBCL patients must have had their diagnosis confirmed histologically. Multiple myeloma patients must have been diagnosed with multiple myeloma by having met all three of the following IMWG criteria:
-- Clonal bone marrow plasma cells >10%
-- Presence of serum and/or urinary M-protein
-- 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
- 2. MCL and DLCBL 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 =>1g/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.)
- 3. Have relapsed or refractory disease after two or more prior treatment regimens, each of which may have consisted of either single or multiple therapies. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.
- 4. Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies
- 5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- 6. Have life expectancy of at least 3 months
- 7. Be =>18 years of age and willing to provide written informed consent
- 8. Temporarily or permanently reside within 2 hours travel time from a study site
- 9. 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
- 10. For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy
- 11. Have an absolute neutrophil count >1,000/mm3
- 12. Have a platelet count >50,000/mm3
- 13. Have total bilirubin <2.0 mg/dL
- 14. Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal
- 15. Have serum creatinine =<2.5 times the upper limit of normal
- 16. Have hemoglobin =>8.5 g/dL
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 1. Have presence of nonsecretory myeloma
- 2. Have evaluable disease only (myeloma patients)
- 3. Have New York Heart Association Class III-IV heart failure classification
- 4. Have uncontrolled autoimmune hemolysis or thrombocytopenia
- 5. Have CNS or leptomeningeal disease
- 6. Have an active infection or serious comorbid medical condition
- 7. Be receiving other concurrent anticancer agents or therapies
- 8. Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening
- 9. Be eligible to receive any other standard therapy available that is known to extend life expectancy
- 10. Be receiving steroids unless they are stable doses of steroids equivalent to 20 mg of prednisone or less, or are steroids administered topically or by inhalation.
- 11. Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T
- 12. Be pregnant or nursing
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma; Multiple Myeloma (MM)
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