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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
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
Evaluate the feasibility of different approaches for CART-EGFR-IL13Ra2 dosing
Proportion of eligible subjects who receive study treatment. Proportion of eligible subjects assigned to arm B who receive all planned doses of CART-EGFR-IL13Ra2 cells
Time frame: Up to 2 years
Progression-free Survival (PFS)
Per RANO 2.0 criteria
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Per RANO 2.0 criteria
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Per RANO 2.0 criteria in participants with measurable disease at the time of study treatment (Treatment Arms A and B) or Post-Surgical Resection (Treatment Arm C)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Per RANO 2.0 criteria in participants with measurable disease at the time of study treatment (Treatment Arms A and B) or Post-Surgical Resection (Treatment Arm C)
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Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration