OncoMatch/Clinical Trials/NCT06973096
CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
Is NCT06973096 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CART-EGFR-IL13Ra2 cells for glioblastoma.
Treatment: CART-EGFR-IL13Ra2 cells — 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 IL3Ra2 (referred to as "CART-EGFR-IL13Ra2 cells"). Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma who have undergone maximal safe surgical resection will be approached for initial study participation. A two-step screening/eligibility process will be utilized. Following informed consent, subjects who meet Step #1 Eligibility Criteria will remain on study and complete a course of radiotherapy (60 Gy) without temozolomide as per their routine cancer care. If there is no overt evidence of disease recurrence/progression following radiotherapy, additional screening tests/procedures will be performed. Subjects who then meet Step #2 Eligibility Criteria will undergo apheresis collection to initiate cell product manufacturing and surgical placement of a CSF-Ventricular Reservoir to allow for intracerebroventricular injection of the CART-EGFR-IL13Ra2 cells. All subjects will receive a single fixed dose of CART-EGFR-IL13Ra2 cells on Day 0 via intracerebroventricular delivery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: EGFR amplification
Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma ... Tumor tissue positive for wild-type EGFR amplification by Neogenomics Laboratories
Required: MGMT unmethylated promoter
MGMT-unmethylated glioblastoma
Required: IDH1 wild-type
the tumor must be IDH wildtype
Required: IDH2 wild-type
the tumor must be IDH wildtype
Prior therapy
Must have received: surgical resection — newly diagnosed
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.
Must have received: radiation therapy — newly diagnosed
Patient scheduled to receive 60 Gy of radiotherapy. Either photon or proton therapy is acceptable.
Cannot have received: bevacizumab (bevacizumab)
Anticipated treatment plan that involves bevacizumab, any other systemic anti-neoplastic therapy, and/or tumor-treating fields as part of 1st line therapy.
Cannot have received: systemic anti-neoplastic therapy
Anticipated treatment plan that involves bevacizumab, any other systemic anti-neoplastic therapy, and/or tumor-treating fields as part of 1st line therapy.
Cannot have received: tumor-treating fields
Anticipated treatment plan that involves bevacizumab, any other systemic anti-neoplastic therapy, and/or tumor-treating fields as part of 1st line therapy.
Cannot have received: bevacizumab (bevacizumab)
Receipt of prior bevacizumab therapy for their newly diagnosed glioblastoma.
Cannot have received: alkylating agent (temozolomide)
Receipt of temozolomide for their newly diagnosed glioblastoma.
Cannot have received: tumor-treating fields
Anticipated post-radiotherapy maintenance treatment that includes tumor treating fields, bevacizumab, or any other anti-neoplastic therapies.
Cannot have received: systemic anti-neoplastic therapy
Anticipated post-radiotherapy maintenance treatment that includes tumor treating fields, bevacizumab, or any other anti-neoplastic therapies.
Lab requirements
Kidney function
Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 30 mL/min and not on dialysis
Liver function
ALT/AST ≤ 3 x ILN; Total bilirubin ≤ 2.0 mg/dl, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/Dl)
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
Adequate organ function defined as: Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 30 mL/min and not on dialysis; ALT/AST ≤ 3 x ILN; Total bilirubin ≤ 2.0 mg/dl, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/Dl); Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA; Must have minimum level of pulmonary reserve defined as > 92% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Pennsylvania · Philadelphia, Pennsylvania
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