Actively Recruiting
CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
Led by University of Pennsylvania · Updated on 2026-05-11
9
Participants Needed
1
Research Sites
884 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
K
Kite Pharma (a Gilead Company)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male or female aged 18 years or older
- Newly diagnosed glioblastoma, EGFR-amplified and MGMT-unmethylated, IDH wildtype as per WHO 2021 CNS tumor classification
- Histopathologic evidence of glioblastoma including microvascular proliferation and/or necrosis
- Maximal safe tumor resection completed (biopsy only not eligible)
- Tumor tissue positive for wild-type EGFR amplification by Neogenomics Laboratories
- Karnofsky Performance Status of 60% or higher
- Scheduled to receive 60 Gy of radiotherapy (photon or proton)
- Completed full course of 60 Gy radiotherapy
- No evidence of disease recurrence or progression after radiotherapy per RANO 2.0 criteria
- Adequate organ function including serum creatinine ≤1.5x ULN or creatinine clearance ≥30 mL/min, ALT/AST ≤3x ILN, total bilirubin ≤2.0 mg/dl (or ≤3.0 mg/dl if Gilbert's syndrome), LVEF ≥45% confirmed by ECHO/MUGA, and pulmonary reserve >92% on room air
You will not qualify if you...
- Active hepatitis B or C infection
- New York Heart Association Class III or IV cardiovascular disability
- Tumors involving thalamus, brain stem, or spinal cord with enhancing disease
- MGMT promoter methylation that is hypermethylated, methylated, low positive methylated, or indeterminate
- Multifocal disease if one or more foci have not undergone maximal safe resection
- Severe active co-morbidity precluding study participation
- Allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, Dextran 40)
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥10 mg prednisone; autoimmune neurologic diseases excluded
- Anticipated first-line treatment including bevacizumab, other systemic anti-neoplastic therapy, or tumor-treating fields
- Any active uncontrolled infection
- Clinical or neurological decline related to disease or radiotherapy precluding participation
- Pregnant or nursing patients; reproductive potential participants must use acceptable birth control
- Prior bevacizumab or temozolomide therapy for newly diagnosed glioblastoma
- Anticipated post-radiotherapy maintenance with tumor treating fields, bevacizumab, or other anti-neoplastic therapies
- Enrollment in another clinical trial for newly diagnosed glioblastoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Abramson Cancer Center Clinical Trials Service
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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