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ACTIVE NOT RECRUITING
NCT02311621
PHASE1

Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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)

BIOLOGICAL

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

BIOLOGICAL

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