A Study to Evaluate the Safety, Tolerance and Initial Efficacy of EGFRvIII CAR-T on Glioblastoma
Status:
Not yet recruiting
Trial end date:
2025-04-14
Target enrollment:
Participant gender:
Summary
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.