NCT05168423Active, not recruitingPhase 1
CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM
Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 22 Nov 2021
- Start date
- 24 Feb 2023
- Primary completion date
- 19 Dec 2039
- Lead sponsor
- University of Pennsylvania
- Diseases
- Glioblastoma
- NCT number
- NCT05168423
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 67
- From 24 Feb 2023 to the primary completion date, 19 Dec 2039
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
Other illness
- 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.
- 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.
Lab values
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Other
- 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.
- Patients who are pregnant or nursing (lactating).
Who the study is looking for
- 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 radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks 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 or tumor biopsy to confirm tumor recurrence 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 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).
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
Related publications
- The critical role of the endogenous immune compartment after CAR T cell therapy in recurrent GBM.Cell · 2026 · PMID 42296961
This page is information, not medical advice. Discuss any trial with your doctor.