Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07209241
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CART-EGFR-IL13Ra2 T cells — BIOLOGICAL
    CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
May 2026
Primary completion
Nov 1, 2042
Completion
Nov 1, 2042

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
  • Active Comparator: Arm B
    Subjects will receive repeated dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
  • Active Comparator: Arm C
    Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 in the pre-operative setting.

Primary Outcome Measure

Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0 [ Time Frame: Up to 15 years following CART-EGFR-IL13Ra2 administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Abramson Cancer Center Clinical Trials Service
215-349-8245

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