UPCC 16321 Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma

Investigation of Safety and Feasibility of CART Cells Targeting EGFR and IL13Ra2 in Recurrent Glioblastoma

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

Brief description of study

This is an open-label phase 1 study to assess the safety and feasibility 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 EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy.

Eligibility of study

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

  • Conditions: 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 radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks 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 or tumor biopsy to confirm tumor recurrence 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 upper limit of normal range and total bilirubin ≤ 2.0 mg/dl, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/dl).
    3. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
    4. 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.

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 safety and feasibility of a treatment involving specialized T cells, known as CART-EGFR-IL13Ra2 cells, for patients with recurrent glioblastoma. The study focuses on patients whose tumors have a specific genetic feature called EGFR amplification.

Participants in this study will receive an infusion of their own T cells that have been modified to target specific proteins found on their cancer cells. These proteins are the cryptic EGFR epitope 806 and IL13Ra2. The study will monitor the safety of this treatment and how well it is tolerated by participants.

  • Who can participate: Adults aged 18 years and older with recurrent glioblastoma, IDH-wildtype, and EGFR amplification are eligible. Participants must have adequate organ function and a Karnofsky Performance Status of 60% or higher, with key exclusions including active infections and certain cardiovascular conditions.
  • Study details: Participants will receive an infusion of CART cells targeting cancer cells. The study will assess the safety and feasibility of this treatment, and participants must agree to use birth control if of reproductive potential.
Updated on 28 Jul 2026. Study ID: 21-1412
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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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