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The main research objective of active comparator is to observe the efficacy and safety of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T cells(EGFRvIII CAR-T cells) injected by local administration (Omaya capsule administration) in the treatment of Glioblastoma(GBM).

Initial dose 22 × 10\^6 cells will adopt accelerated titration (ATD); 60 × 10\^6 cells，160 × 10\^6 cells and 220 × 10\^6 cells will use the BOIN method to increase the dose. The planned dose increase scheme is divided into accelerated titration stage (ATD) and BOIN stage

Infusion of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T(EGFRvIII CAR-T) with Omaya capsule

Targeted Epidermal Growth Factor Receptor Variant III(EGFRvIII) autochimeric antigen receptor T cell injection

Yang Xuejun

Zuo Ran

This is a single-center, open, dose-increasing study. For subjects with recurrent glioblastomaIt ,is estimated that about 22 subjects will be enrolled, The main purpose was to evaluate the safety and tolerance of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T(EGFRvIII CAR-T) in the treatment of patients with recurrent glioblastoma.The secondary purpose is to preliminarily evaluate the anti-tumor activity of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T(EGFRvIII CAR-T) in the treatment of patients with recurrent glioblastoma, and preliminarily evaluate the relationship between the clinical efficacy, safety and pharmacokinetics of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T cells(EGFRvIII CAR-T cells) preparation, as well as their correlation with tumor markers or other potential biomarkers.

This clinical study is an open clinical study, including dose increasing stage and expansion stage. The main objective of the study was to observe the efficacy and safety of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T cells(EGFRvIII CAR-T cells) in the treatment of Glioblastoma (GBM) by local administration (Omaya capsule administration). The study will be divided into the following stages: screening stage, baseline stage, treatment stage, short-term follow-up and long-term follow-up stage.

A Study to Evaluate the Safety, Tolerance and Initial Efficacy of EGFRvIII CAR-T on Glioblastoma

An Open Clinical Study to Evaluate the Safety, Tolerance and Initial Efficacy of Epidermal Growth Factor Receptor Variant III Chimeric Antigen Receptor T(EGFRvIII CAR-T) in the Treatment of Recurrent Glioblastoma

Will assess dose limiting toxicity and all toxicities. Toxicity is the primary endpoint and will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Rates and associated 95% Clopper and Pearson binomial confidence limits (95% confidence interval \[CI\]) will be estimated for participants' experiencing dose limiting toxicity (DLT). All toxicities and side effects will be summarized in tables by dose, time period, organ, and severity.

A toxicity that causes side effects that are serious enough to prevent an increase in dose or level of that treatment.

Will assess chimeric antigen receptor (CAR) T levels and phenotype detected in peripheral blood (PB) (absolute number per ul by flow).

Will assess EGFRvIII CAR gene copies in peripheral blood (PB)（Q-PCR method ). Statistical and graphical methods will be used to describe persistence and expansion.

Statistical and graphical methods will be used to describe persistence and expansion.

By Response Assessment in Neuro-Oncology (RANO) criteria with the need for Avastin as an additional indicator of progression.

Progression is defined by RANO with the need for Avastin as an additional indicator of progression.

Kaplan Meier methods will be used to estimate median CR and graph the results.

Kaplan Meier methods will be used to estimate median PR and graph the results.

Kaplan Meier methods will be used to estimate median SD and graph the results.

Kaplan Meier methods will be used to estimate median PD and graph the results.

Kaplan Meier methods will be used to estimate median PFS and graph the results.

Kaplan Meier methods will be used to estimate median OS and graph the results.

Will estimate the mean and standard error for change from baseline during treatment and post treatment in the quality of life functioning scale, symptom scale and item scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30（EORTC QLQ-C30）. Health-Related Quality of Life and Sympotoms will be assessed from the International Validation Study of the EORTC Brain Cancer Module(EORTC QLQ-BN20)

Spots Global Cancer Trial Database for targeted epidermal growth factor receptor variant iii(egfrviii) autochimeric antigen receptor t cell injection