Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
ConditionRecurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Tumors primarily localized to the brain stem or spinal cord.
Trial design
Design model
Sequential
Treatments tested in this trial
CART-EGFR-IL13Ra2 T cells
Biological/VaccineCART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Treatment groups
12 Participants
are divided into 3 treatment groupsGroup A: Arm AActive comparator 1 intervention
Group B: Arm BActive comparator 1 intervention
Group C: Arm CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 administration2
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 administrationSecondary outcomes
1
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 years2
Progression-free Survival (PFS)
Per RANO 2.0 criteria
Time frame
Up to 15 years following CART-EGFR-IL13Ra2 administration3
Overall Survival (OS)
Per RANO 2.0 criteria
Time frame
Up to 15 years following CART-EGFR-IL13Ra2 administration4
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 administrationSponsors and contacts
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Source ClinicalTrials.gov