Pilot/Feasibility Study To Evaluate The Safety Of Cellular Immunotherapy For CD19+ Follicular Lymphoma Using Autologous Cytolytic T Cells Genetically-Modified To Be CD19-Specific And Co-Express HyTK
- Determine the safety and feasibility of cellular adoptive immunotherapy using
autologous cytotoxic T lymphocytes genetically modified to express a CD19-specific
chimeric immunoreceptor gene and HyTK selection/suicide gene in patients with relapsed
or refractory follicular non-Hodgkin's lymphoma.
- Determine the in vivo persistence of adoptively transferred cytolytic T cells in
patients treated with lymphodepleting therapy comprising rituximab and fludarabine.
- Assess the development of host immune responses against the CD19-specific chimeric
immunoreceptor gene and/or HyTK selection/suicide gene.
- Determine the safety of low-dose interleukin-2 in supporting in vivo persistence of
adoptively transferred cytotoxic T cells.
- Determine the anti-tumor activity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, pilot study.
- Leukapheresis: Patients undergo leukapheresis for collection of peripheral blood
mononuclear cells (PBMCs). CD3-positive cytotoxic T lymphocytes (CTLs) are isolated and
genetically modified to express a CD19-specific chimeric immunoreceptor and the HyTK
fusion protein, and are then expanded in vitro.
- Lymphodepleting therapy: Patients receive rituximab and fludarabine prior to T-cell
- Cellular adoptive immunotherapy and interleukin-2 (IL-2): Patients receive a total of 5
infusions of genetically modified autologous T cells. Patients may receive low-dose
IL-2 subcutaneously after infusions 3, 4, and 5.
- Additional IL-2 therapy: After the completion of the last T-cell infusion, patients
with evidence of adoptively transferred T cells may receive additional IL-2.
After completion of study treatment, patients are followed periodically for approximately 65
days and then annually for at least 15 years.
PROJECTED ACCRUAL: At least 5 patients will be accrued for this study within 3 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|