Status:
RECRUITING
Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
Lead Sponsor:
University of Pennsylvania
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART...
Eligibility Criteria
Inclusion
- Signed, written informed consent
- Male or female age ≥ 18 years
- Patients with glioblastoma, IDH-wildtype (as defined by WHO 2021 Classification of CNS Tumors) that has recurred following prior radiotherapy1. For patients with tumors harboring methylation of the MGMT promoter, a t l east 1 2 w eeks must have elapsed since completion of first-line radiotherapy.
- Tumor tissue positive for wild-type EGFR amplification by NeoGenomics Laboratories. Archival tumor from patient's initial surgery at time of original diagnosis or recently collected tumor from time of recurrence are acceptable.
- Surgical tumor resection for disease control/management (Arms A, B, C) or tumor biopsy to confirm tumor recurrence (Arms A and B only) is clinically indicated in the opinion of the physician-investigator.
- Adequate organ function defined as:
- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 ml/min and not on dialysis.
- ALT/AST ≤ 3 x ULN
- 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 a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
- Karnofsky Performance Status ≥ 60%.
- Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.
Exclusion
- Active hepatitis B or hepatitis C infection.
- Any other active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Tumors primarily localized to the brain stem or spinal cord.
- Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
- Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg daily of prednisone. Patients with autoimmune neurological diseases (such as MS or Parkinson's) will be excluded.
- Patients who are pregnant or nursing (lactating).
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Key Trial Info
Start Date :
December 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2042
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07209241
Start Date
December 3 2025
End Date
November 1 2042
Last Update
December 12 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104