CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy (NCT06973096) | Clinical Trial Compass
RecruitingPhase 1
CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
United States9 participantsStarted 2025-07-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form
. Male or females age ≥ 18 years.
. Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma (as defined by WHO 2021 Classification for CNS Tumors, including that the tumor must be IDH wildtype). The tumor must also have histopathologic evidence of glioblastoma (i.e., presence of microvascular proliferation and/or necrosis).
. Patients must have undergone maximal safe resection of the tumor as per routine cancer care. Patients who have had a biopsy only are not eligible.
. Tumor tissue positive for wild-type EGFR amplification by Neogenomics Laboratories
. Karnofsky Performance Status ≥ 60%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Timeframe: Up to 15 years following CART-EGFR-IL13Ra2 administration
2
Occurrence of treatment-limiting toxicities (TLTs)
. Patient scheduled to receive 60 Gy of radiotherapy. Either photon or proton therapy is acceptable.
Exclusion criteria
. Active hepatitis B or hepatitis C infection
. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
. Tumors with enhancing disease involving the thalamus, brain stem or spinal cord.
. Tumors with an MGMT promoter methylation result of hypermethylated, methylated, low positive methylated, or indeterminate.
. Multifocal disease if ≥ 1 focus of tumor has not undergone maximal safe resection
. Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.