Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM (NCT07209241) | Clinical Trial Compass
RecruitingPhase 1
Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
United States12 participantsStarted 2025-12-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Timeframe: Up to 15 years following CART-EGFR-IL13Ra2 administration
2
Occurrence of treatment-limiting toxicities (Arms A and B only)
Timeframe: Up to 28 days following CART-EGFR-IL13Ra2 administration
. Tumors primarily localized to the brain stem or spinal cord.
✕. Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
✕. Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
✕. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg daily of prednisone. Patients with autoimmune neurological diseases (such as MS or Parkinson's) will be excluded.
✕. Patients who are pregnant or nursing (lactating).