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Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01
Sponsor: Seattle Children's Hospital
Summary
Patients with recurrent or refractory neuroblastoma are resistance to conventional chemotherapy. For this reason, the investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell through the recognition of CD171, a protein expressed of the surface of the neuroblastoma cell in patients with neuroblastoma. This is a phase 1 study designed to determine the maximum tolerated dose of the CAR+ T cells.
Official title: A Phase 1 Feasibility and Safety Study of Cellular Immunotherapy for Recurrent/Refractory Neuroblastoma Using Autologous T-cells Lentivirally Transduced to Express CD171-specific Chimeric Antigen Receptors
Key Details
Gender
All
Age Range
18 Months - 26 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2014-11-25
Completion Date
2038-11
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells)
Intravenous infusion of autologous T cells transduced to express 4-1BB:zeta CD171CAR and EGFRt (2nd generation T cells)
Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells)
Intravenous infusion of autologous T cells transduced to express CD28:4-1BB:zeta CD171CAR and EGFRt
Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells)
Intravenous infusion of autologous T cells transduced to express 4-1BB:zeta CD171CAR and EGFRt (long spacer 2nd generation T cells)
Locations (1)
Seattle Children's Hospital
Seattle, Washington, United States