Trials / Unknown
UnknownNCT01435720
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Senesco Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SNS01-T | 0.05 mg/kg twice weekly x 6 weeks |
| BIOLOGICAL | SNS01-T | 0.2 mg/kg twice weekly x 6 weeks |
| BIOLOGICAL | SNS01-T | 0.375 mg/kg twice weekly x 6 weeks |
| BIOLOGICAL | SNS01-T | 0.0125 mg/kg twice weekly x 6 weeks |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2014-10-01
- Completion
- 2014-12-01
- First posted
- 2011-09-19
- Last updated
- 2014-09-11
Locations
7 sites across 2 countries: United States, South Africa
Source: ClinicalTrials.gov record NCT01435720. Inclusion in this directory is not an endorsement.