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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Abramson Cancer Center Clinical Trials, MD, MSCE
PMCancerResearch@pennmedicine.upenn.edu
215-349-8245
Backup
University of Pennsylvania
PMCancerResearch@pennmedicine.upenn.edu
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2042-11-01
Participants
Target number of participants: 12
Treatments
Active_comparator: Arm A
Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
Active_comparator: Arm B
Subjects will receive repeated dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
Active_comparator: Arm C
Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 in the pre-operative setting.
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov