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Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM

Phase Ib, Open-Label Study of CART-EGFR-IL13Rα2 Cells Administered Following Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients With EGFR-Amplified Recurrent Glioblastoma

NCT07209241•University of Pennsylvania

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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).

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 3, 2025

Primary Completion Date

November 1, 2042

Completion Date

November 1, 2042

Last Updated

December 12, 2025

Enrollment

ESTIMATED participants

Conditions

Recurrent Glioblastoma

Interventions

CART-EGFR-IL13Ra2 T cells

BIOLOGICAL

Contacts

Abramson Cancer Center Clinical Trials, MD, MSCE

CONTACT

215-349-8245 PMCancerResearch@pennmedicine.upenn.edu

University of Pennsylvania

CONTACT

PMCancerResearch@pennmedicine.upenn.edu

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

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