Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)

NCT ID: NCT01435720

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed 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.

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Mantle Cell Lymphoma in Relapse; Diffuse Large B Cell Lymphoma in Relapse; Other B Cell Lymphoma in Relapse; Plasma Cell Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

0.0125 mg/kg

Group Type: EXPERIMENTAL

SNS01-T

Intervention Type: BIOLOGICAL

0.0125 mg/kg twice weekly x 6 weeks

Cohort 2

0.05 mg/kg

Group Type: EXPERIMENTAL

SNS01-T

Intervention Type: BIOLOGICAL

0.05 mg/kg twice weekly x 6 weeks

Cohort 3

0.2 mg/kg

Group Type: EXPERIMENTAL

SNS01-T

Intervention Type: BIOLOGICAL

0.2 mg/kg twice weekly x 6 weeks

Cohort 4

0.375 mg/kg

Group Type: EXPERIMENTAL

SNS01-T

Intervention Type: BIOLOGICAL

0.375 mg/kg twice weekly x 6 weeks

Interventions

SNS01-T

0.05 mg/kg twice weekly x 6 weeks

Intervention Type: BIOLOGICAL

SNS01-T

0.2 mg/kg twice weekly x 6 weeks

Intervention Type: BIOLOGICAL

SNS01-T

0.375 mg/kg twice weekly x 6 weeks

Intervention Type: BIOLOGICAL

SNS01-T

0.0125 mg/kg twice weekly x 6 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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.

3. 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.

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 2

6. Have life expectancy of at least 3 months

7. Be ≥18 years of age and willing to provide written informed consent

8. 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

9. For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy

10. Have an absolute neutrophil count >1,000/mm3

11. Have a platelet count >75,000/mm3

12. Have total bilirubin <2.0 mg/dL

13. Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal

14. Have serum creatinine ≤3 times the upper limit of normal

15. Have hemoglobin ≥8.0 g/dL

Exclusion Criteria

1. Have presence of nonsecretory myeloma

2. Have an indolent lymphoma such as follicular lymphoma unless the disease is rapidly progressing

3. Requires renal dialysis

4. Have New York Heart Association Class III-IV heart failure classification

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 or 5 half-lives, if known, whichever is shorter

9. Be eligible to receive any other standard therapy available that is known to extend life expectancy

10. Be currently receiving steroids unless equivalent to 20 mg of prednisone or less

11. Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T

12. Be pregnant or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senesco Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A Lust, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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

Countries

United States; South Africa

Other Identifiers

SNS01-T-001

Identifier Type: -

Identifier Source: org_study_id