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Neuroepithelioma

anti-EGFR CAR T

Zonghai Li, M.D

zonghai li, m.d

Zonghai Li, M.D.

Yongming Qiu, M.D.

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.

CAR T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR

Genetically Modified T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR

RenJi Hospital

local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10\^7 cells) for 1-2 minutes each time.

Targeted IL-13 Rα2 UCAR-T cell injection

Targeted B7-H3 UCAR-T cell injection

Qing Lan, Doctor

Qing Zhu, Doctor

The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.

Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma

The proportion of patients whose tumor size decreases to the expected value and can continue to meet the expected minimum time limit。

The time from enrolling into the trial to the first occurrence of disease progression or death from any cause。

Soochow T-Maximun Biotechnology Co. LTD

Second Affiliated Hospital of Soochow University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CAR T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR	NCT02331693	Advanced Glioma	anti-EGFR CAR T	18 Years - 70 Years	RenJi Hospital
Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma	NCT05752877	Advanced Glioma Complication of...	Targeted IL-13 ... Targeted B7-H3 ...	18 Years - 70 Years	Second Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for advanced glioma