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 range18 Years
SexALL
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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%
✓. 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
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)
✕. 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.