Transfer of Genetically Engineered Lymphocytes in Melanoma Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The goal of this study is to establish the recommended phase two dose of autologous T cell receptor transduced T cells when administered with low dose IL-2 to stage IV melanoma patients following a non-myeloablative and lymphodepleting chemotherapy preparative regimen. A secondary objective is to ev...
The goal of this study is to establish the recommended phase two dose of autologous T cell receptor transduced T cells when administered with low dose IL-2 to stage IV melanoma patients following a non-myeloablative and lymphodepleting chemotherapy preparative regimen. A secondary objective is to evaluate biologic and immunologic parameters associated with the adoptively transferred T cell receptor transduced T cells, including auditory and visual changes. The investigators believe the infusion of T cell receptor gene modified autologous T cells can mediate objective clinical responses in stage IV melanoma patients.
Tracking Information
- NCT #
- NCT01586403
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Michael Nishimura, PhD Loyola University Chicago
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