drugset
drugset / Trial / NCT02311621

Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

NCT02311621 ↗

Phase 1 Active not recruiting 65 enrolled Seattle Children's Hospital Ben Towne Center for Childhood Cancer Research · collabThe Evan Foundation · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-11-25
Primary completion
2023-11
Completion
2038-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) Unknown 1e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) Unknown 5e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) Unknown 1e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) Unknown 5e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) Unknown 1e+08 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) Unknown 1e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) Unknown 5e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) Unknown 1e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) Unknown 5e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) Unknown 1e+08 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) Unknown 1e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) Unknown 5e+06 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) Unknown 1e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) Unknown 5e+07 cells/kg Intravenous
Subject Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) Unknown 1e+08 cells/kg Intravenous

Indications

ganglioneuroblastoma neuroblastoma