Blood-Brain Barrier Disruption Using Exablate Magnetic Resonance-Guided Low Intensity Focused Ultrasound With Microbubbles in Combination With T-Cell Infusion in Patients With Newly Diagnosed Diffuse Midline Glioma (LIFT)

This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for Diffuse Midline Glioma (DMG), an aggressive brain tumor with a very poor prognosis - an average one-year overall survival. This study combines blood-brain barrier (BBB) disruption (BBBD) using low-intensity focused ultrasound (LIFU) and microbubble treatment, and intravenous infusion of autologous, tumor multi-antigen associated specific cytotoxic T lymphocyte (TAA-T) therapy. The TAA-T cell investigational product in this protocol is manufactured to target Preferentially Expressed Antigen of

Trial Details

NCT ID
NCT07796061
Phase
PHASE1
Sponsor
Children's National Research Institute
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • TAA-T Cell
  • BBB Disruption
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Inclusion Criteria for Screening and Procurement:
  • Age ≥ 3 and ≤ 25 years
  • Diagnosis of pontine or thalamic DMG
  • Group A: newly diagnosed pontine DMG after completion of standard radiation therapy; radiographic diagnosis is defined as tumors with a pontine epi…

For full eligibility, visit ClinicalTrials.gov.

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