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Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

NCT02311621 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • The Evan Foundation

    collaborator OTHER

  • Ben Towne Center for Childhood Cancer Research

    collaborator OTHER

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Catherine Albert, MD · Seattle Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-25
Primary Completion
2023-11-30
Completion
2038-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02311621 on ClinicalTrials.gov