CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06973096
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CART-EGFR-IL13Ra2 cells — DRUG
    autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR epitope 806 and a humanized scFv targeting IL13Ra2; both scFvs are fused to the 4-1BB and CD3ζ signaling domains.
  • Rituximab or Rituximab biosimilar — BIOLOGICAL
    375 mg/m2/day x 1 day
  • Fludarabine + Cyclophosphamide combination — DRUG
    Fludarabine: 30mg/m2/day x 3 days; Cyclophosphamide: 300mg/m2/day x 3 days

Study Details

This is an open-label phase 1 study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy 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 newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma, without evidence of disease recurrence/progression following completion of initial radiotherapy.

Key Dates

Start date
Jul 18, 2025
Status verified
May 2026
Primary completion
Jul 31, 2042
Completion
Jul 31, 2042

Study Design

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

Arms

  • Experimental: Cohort A (Single Fixed Dose)
    All subjects will receive a single fixed dose of CART-EGFR-IL13Ra2 cells on Day 0 via intracerebroventricular delivery.
  • Experimental: Cohort B (Repeat Cycles Following Lymphodepletion)
    CART-EGFR-IL13Ra2 cells will be administered via intracerebroventricular delivery in q6 week cycles of treatment, following lymphodepletion with fludarabine, cyclophosphamide, and rituximab.

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
[email protected]
215-349-8245

Find similar trials in Philadelphia, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Pennsylvania· Philadelphia, PA

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