EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors

Glioma Clinical Trial

Official title: Phase 1 Study of EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric Central Nervous System Tumors

Status Active, not recruiting

Clinical Trial Summary

This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells that are lentivirally transduced to express an EGFR806 specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor cavity or the ventricular system in children and young adults with recurrent or refractory EGFR-positive CNS tumors. The primary objectives of this protocol are to evaluate the feasibility, safety, and tolerability of CNS-delivered fractionated CAR T cell infusions employing intra-patient dose escalation. Subjects with supratentorial tumors will receive sequential EGFR806-specific CAR T cells delivered into the tumor resection cavity, subjects with infratentorial tumors will receive sequential CAR T cells delivered into the fourth ventricle, and subjects with leptomeningeal disease will receive sequential CAR T cells delivered into the lateral ventricle. The secondary objectives are to assess CAR T cell distribution within the cerebrospinal fluid (CSF), the extent to which CAR T cells egress into the peripheral circulation, and EGFR expression at recurrence of initially EGFR-positive tumors. Additionally, tumor response will be evaluated by magnetic resonance imaging (MRI) and CSF cytology. The exploratory objectives are to analyze CSF specimens for biomarkers of anti-tumor CAR T cell presence and functional activity.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Atypical Teratoid/Rhabdoid Tumor
• Central Nervous System Neoplasms
• Central Nervous System Tumor, Pediatric
• Choroid Plexus Carcinoma
• Ependymoma
• Germ Cell Tumor
• Glioma
• Medulloblastoma
• Neoplasms
• Nervous System Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Pinealoma
• Pineoblastoma
• Primitive Neuroectodermal Tumor
• Rhabdoid Tumor

• NCT number: NCT03638167
• Study type: Interventional
• Source: Seattle Children's Hospital
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 19, 2019
• Completion date: March 2040