Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing TAA-T Cell for DMG

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.

Official registry: https://clinicaltrials.gov/study/NCT07796061 · Children's National Research Institute · enrollment listed as 45

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TAA-T Cell, or BBB Disruption. The registry lists allocation as randomized. 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.

They plan to enroll about 45 people at Washington D.C.. Taking part typically means an infusion or injection of a biologic, using or being fitted with a device plus check-ins.

Official title (unrewritten)

A Safety and Feasibility Study to Evaluate Blood-Brain Barrier Disruption Using Exablate MR-Guided Low Intensity Focused Ultrasound With Microbubbles in Combination With Preferentially Expressed Antigen of Melanoma (PRAME), Survivin, and Wilms Tumor 1 (WT1)-Targeting Tumor Associated Antigen-specific T-Cell Infusion in Patients With Newly Diagnosed Diffuse Midline Glioma (LIFT)

Interventions: TAA-T Cell, BBB Disruption

Primary outcome (registry wording): Safety Evaluation

Who it is for (from inclusion criteria)

  • Ages 3 Years to 25 Years
  • who can join 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 epicenter and diffuse intrinsic involvement of the pons - tissue diagnosis is not required

Public study contact (from the registry)

Luca Szalontay, MD

202-476-1725

LSZALONTAY@childrensnational.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07796061 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07796061?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07796061?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary