NCT05802693

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Targeted Epidermal Growth Factor Receptor Variant III(EGFRvIII) autochimeric antigen receptor T cell injection	Infusion of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T(EGFRvIII CAR-T) with Omaya capsule

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2023-04-06
• Last updated: 2023-08-25