IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06946680
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High-grade Glioma

Eligibility Criteria

Sex
ALL
Age
4 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells — BIOLOGICAL
    Single dose of 8R-70CAR T cells administered IV

Study Details

This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2045

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Newly Diagnosed High Grade Glioma (ndHGG)
    Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg
  • Experimental: Recurrent High Grade Glioma (rHGG)
    Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg
  • Experimental: Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
    Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg

Primary Outcome Measure

Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event) [ Time Frame: administration of 8R-70CAR T to 28 days post-infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida Health Children's HospitalGainesvilleFlorida32608-

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By research site
University of Florida Health Children's Hospital· Gainesville, FL

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