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
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.
Arms & interventions
- BiologicalCART-EGFR-IL13Ra2 T cells
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Outcome measures
Primary
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Type, frequency, severity, and attribution of adverse events
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Occurrence of treatment-limiting toxicities (Arms A and B only)
Type, frequency, severity, and attribution of treatment limiting adverse events as defined in protocol section 8.1.7
Time frame: Up to 28 days following CART-EGFR-IL13Ra2 administration
Secondary
Evaluate the feasibility of different approaches for CART-EGFR-IL13Ra2 dosing
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Eligibility criteria
Study locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104