Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT02331693
Status:
UNKNOWN
Last Update Posted:
2015-01-06
First Post:
2015-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAR T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Genetically Modified T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
\- 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: