Status:
RECRUITING
CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
Lead Sponsor:
University of Pennsylvania
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Step #1
- 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.
- Step #1
Exclusion
- 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.
- Anticipated treatment plan that involves bevacizumab, any other systemic anti-neoplastic therapy, and/or tumor-treating fields as part of 1st line therapy.
- Step #2 Inclusion Criteria:
- Patient completed full course of radiotherapy to 60 Gy.
- No overt evidence of disease recurrence/progression post-radiotherapy confirmed by RANO 2.0 criteria.
- Karnofsky Performance Status ≥ 60%
- 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
- Step #2
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2042
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06973096
Start Date
July 18 2025
End Date
July 1 2042
Last Update
July 24 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104