CAR T-cell Therapy for Glioblastoma
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on bevacizumab, you must not have received it within 3 months before eligibility confirmation.
What data supports the effectiveness of the treatment CART-EGFR-IL13Ra2 Cells for glioblastoma?
Research shows that CAR T-cell therapy targeting IL13Rα2, a protein found in glioblastoma but not in normal brain tissue, can lead to tumor regression and improved survival in animal models and a patient case study. This suggests that CART-EGFR-IL13Ra2 Cells could be effective in treating glioblastoma by specifically targeting cancer cells without affecting healthy brain cells.12345
Is CAR T-cell therapy for glioblastoma safe for humans?
What makes the CAR T-cell therapy for glioblastoma unique?
What is the purpose of this trial?
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy. This study will take place in two parts: an initial dose escalation phase followed by a dose exploration phase. In the dose expansion phase, the maximum tolerated dose (MTD) of CART-EGFR-IL13Ra2 cells will be determined using a standard 3+3 design. Once the MTD has been determined, the dose exploration phase will allow for further identification of a recommended dose for expansion (RDE) as well as the safety and feasibility of alternative dosing schedules.
Research Team
Stephen Bagley, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for adults over 18 with recurrent glioblastoma, IDH-wildtype, after radiotherapy. Candidates must have adequate organ function, EGFR-amplified tumors confirmed by specific tests, and agree to use birth control. Excluded are those with active hepatitis B/C, severe comorbidities, recent bevacizumab treatment, autoimmune diseases needing high-dose steroids or pregnant/nursing women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single fixed dose of CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0, with dose escalation based on cohort assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment, with formal DLT evaluations performed after the 3rd subject in each cohort reaches the Day 28 safety follow-up visit
Long-term follow-up
Participants are monitored for progression-free survival and objective response rate over an extended period
Treatment Details
Interventions
- CART-EGFR-IL13Ra2 Cells
CART-EGFR-IL13Ra2 Cells is already approved in United States for the following indications:
- Glioblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Tmunity Therapeutics
Industry Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Kite Pharma (a Gilead Company)
Collaborator
Tmunity Therapeutics, a wholly owned subsidiary of Kite Pharma (a Gilead company)
Collaborator