UPCC 10325: Phase Ib, Open-Label Study of CART-EGFR-IL13R2 Cells Administered with Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients with EGFR-Amplified Recurrent Glioblastoma

Study of Investigational Cells for Recurrent Glioblastoma

Enrolling By Invitation
18 years or above
All
Phase 1
12 participants needed
1 Location

Brief description of study

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-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Recurrent Glioblastoma
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  1. Signed, written informed consent
  2. Male or female age ≥ 18 years
  3. 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.
  4. 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.
  5. 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.
  6. Adequate organ function defined as:
    1. Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 ml/min and not on dialysis.
    2. ALT/AST ≤ 3 x ULN
    3. Total bilirubin ≤ 2.0 mg/dL, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/dL)
    4. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
    5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
  7. Karnofsky Performance Status ≥ 60%.
  8. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.

Exclusion Criteria:

  1. Active hepatitis B or hepatitis C infection.
  2. Any other active, uncontrolled infection.
  3. Class III/IV cardiovascular disability according to the New York Heart Association Classification
  4. Tumors primarily localized to the brain stem or spinal cord.
  5. Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
  6. Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
  7. 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.
  8. Patients who are pregnant or nursing (lactating).
  9. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).

This study investigates the use of investigational cells called CART-EGFR-IL13Ra2 in patients with recurrent glioblastoma, a type of brain cancer. The study aims to evaluate the safety and effectiveness of these cells in patients whose cancer has returned after previous treatment.

Participants will receive CART-EGFR-IL13Ra2 cells along with chemotherapy or before surgery. The study will monitor how the body processes these cells and any effects they have on the cancer. Participants will undergo procedures such as tumor resection or biopsy to confirm recurrence and assess the treatment's impact.

  • Who can participate: Adults aged 18 and older with recurrent glioblastoma that has shown EGFR amplification may be eligible. Participants must have adequate organ function and a Karnofsky Performance Status of at least 60%.
  • Study details: Participants will receive investigational cells either with chemotherapy or before surgery. They must agree to use birth control and meet specific health criteria. The study involves monitoring the body's response to the treatment.
Updated on 11 May 2026. Study ID: 25-1612
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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