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

UNKNOWNPHASE1/PHASE2

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

NCT01435720•Senesco Technologies, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

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
+2 more criteria

Locations (7)

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

Key Dates

Start Date

September 1, 2011

Primary Completion Date

October 1, 2014

Completion Date

December 1, 2014

Last Updated

September 11, 2014

Enrollment

ESTIMATED participants

Conditions

Multiple MyelomaMultiple Myeloma in RelapseMantle Cell Lymphoma in RelapseDiffuse Large B Cell Lymphoma in RelapseOther B Cell Lymphoma in RelapsePlasma Cell Leukemia

Interventions

SNS01-T

BIOLOGICAL

SNS01-T

BIOLOGICAL

SNS01-T

BIOLOGICAL

SNS01-T

BIOLOGICAL

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Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma