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Peds IMPACTNCT06946680

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)

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 13 versions: 11 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Nov 2026 to Jan 2027
    • Eligibility criteria expanded, about 70 words
    • Site details revised
    • Collaborators: details revised at 1 of 3 entries
  2. Start date: Jul 2026 to Nov 2026v12
  3. Start date: Mar 18, 2025 to Jul 2026v10 Show 6 more changesShow less
    • Trial status changed: Active, Not Recruiting → Not Yet Recruiting
    • Enrollment increased: 18 → 24 participants
    • Trial arms changed: 1 → 3
    • Eligibility criteria expanded, about 600 words
    • Study description expanded, about 14 words
    • Study title expanded, about 12 words
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  5. Eligibility criteria revised
    • Collaborators: 1 to 3
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date changed from estimate of Sep 1, 2025 to Mar 18, 2025v6
  2. Site contact updatedv5
  3. Start date: Aug 2025 to Sep 1, 2025v4
  4. Start date: Jun 2025 to Aug 2025
    • Eligibility criteria expanded, about 19 words
    v3
  5. Start date: May 2025 to Jun 2025v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event)
Timeframe: administration of 8R-70CAR T to 28 days post-infusion
Prevalence of enrolled subjects who receive a qualified immunotherapy investigational product.
Timeframe: Enrollment up to 18 weeks
Maximum tolerated dose (MTD) dose-finding endpoint based on Dose-Limiting-Toxicity (DLT) incidence
Timeframe: administration of 8R-70CAR T to 28 days post-infusion

Arms and interventions

Newly Diagnosed High Grade Glioma (ndHGG)Experimental

Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg

Recurrent High Grade Glioma (rHGG)Experimental

Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg

Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)Experimental

Participants will receive either 8R-70CAR T 1 x 10\^7 cells/kg or 1 x 10\^8 cells/kg

Biologicals: Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

Sites

1 site in 1 country

  • University of Florida Health Children's HospitalGainesville, Florida, United States