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
Qualifiers
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
Treatments tested in this trial
- CART-EGFR-IL13Ra2 T cells
Treatment groups
12 Participants
are divided into 3 treatment groupsLocations
1University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Source ClinicalTrials.gov