RecruitingPhase 1NCT06973096

CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy

Phase 1 Open-label Study Evaluating the Safety of CART-EGFR-IL13Rα2 Cells in Patients With Newly Diagnosed, EGFR-Amplified, MGMT-unmethylated Glioblastoma Following Completion of Initial Radiotherapy

Sponsor

University of Pennsylvania

Enrollment

9 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

Summary

This is an open-label phase 1 study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma, without evidence of disease recurrence/progression following completion of initial radiotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized CAR-T cell therapy — an immune cell treatment engineered in the lab from the patient's own blood — for people with newly diagnosed aggressive brain cancer (glioblastoma) after radiation therapy. **You may be eligible if...** - You are 18 or older with a newly diagnosed glioblastoma (a fast-growing brain tumor) - Your tumor has a specific genetic feature called EGFR amplification and is IDH wildtype (confirmed by a specific lab) - Your tumor does NOT have a protective MGMT methylation marker - You have undergone maximal safe surgical removal of the tumor (not just a biopsy) - Your functional status (Karnofsky score) is 60% or higher - You are scheduled to begin radiation therapy **You may NOT be eligible if...** - Your tumor was only biopsied, not surgically removed - Your tumor does not have EGFR amplification - You have other significant health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCART-EGFR-IL13Ra2 cells

autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR epitope 806 and a humanized scFv targeting IL13Ra2; both scFvs are fused to the 4-1BB and CD3ζ signaling domains.

BIOLOGICALRituximab or Rituximab biosimilar

375 mg/m2/day x 1 day

DRUGFludarabine + Cyclophosphamide combination

Fludarabine: 30mg/m2/day x 3 days; Cyclophosphamide: 300mg/m2/day x 3 days