Advanced Glioma Clinical Trial
Official title:
Genetically Modified T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR
The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize EGFR overexpressed in tumor cells is safe and effective for patients with EGFR-overexpressing malignant glioma.
BACKGROUND:
- Patients with advanced gliomas have very limited treatment options. Epidermal Growth
Factor Receptor (EGFR) is often amplified in patients with glioblastoma (GBM) and has been
regarded a suitable target for GBM treatment.
The investigators have constructed lentiviral vector that contains a chimeric antigen
receptor (CAR) that recognizes overexpressed EGFR in tumor cells but not EGFR in normal
cells, which can be used to mediate genetic transfer of this CAR with high efficiency
without the need to perform any selection.
OBJECTIVES:
Primary Objectives To evaluate the safety of the administration of anti-EGFR CAR engineered
T lymphocytes in patients receiving the non-myeloablative conditioning regimen, and
aldesleukin
Secondary objectives To determine whether the glioma will regress after the patients receive
anti-EGFR CAR-engineered T lymphocytes and aldesleukin following a nonmyeloablative but
lymphoid depleting preparative regimen.
ELIGIBILITY:
Histologically proven glioblastoma or glisarcoma overexpressing EGFR as determined by IHC,
Western blot, FISH or RT-PCR.
Failed prior standard treatment with radiotherapy with or without chemotherapy. Cardiac,
pulmonary and laboratory parameters within acceptable limits
DESIGN:
The study will be conducted using a Phase I design. Patients will receive a
non-myeloablative but lymphocyte depleting preparative regimen consisting of
cyclophosphamide and fludarabine followed by intravenous infusion of ex vivo tumor reactive,
CAR gene-transduced T cells, plus IV aldesleukin.
A total of 10 patients may be enrolled over a period of 1-2 years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05752877 -
Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma
|
N/A |