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NCT05768880 · ClinicalTrials.gov registry record · Phase 1
Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors
A Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05768880: Active Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, sponsored by Seattle Children's Hospital.
NCT05768880 is a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 72 participants, below the 133-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05768880, a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with SC-CAR4BRAIN, an autologous CD4+ and CD8+ T cells lentivirally transduced to express to express combinations of B7-H3, EGFR806, HER2, and IL13-zetakine chimeric antigen receptors (CAR). CAR T cells are delivered via an indwelling catheter into the ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors. A child or young adult meeting all eligibility criteria, including having a CNS catheter placed into their ventricular system, and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that target B7H3, EGFR806, HER2, and IL13-zetakine on tumor cells. Patients will be assigned to 1 of 2 treatment Arms based on the type of their tumor: * Arm A is for patients with DIPG (meaning primary disease localized to the pons, metastatic disease is allowed) anytime after standard radiation OR after progression. * Arm B is for patients with non-pontine DMG (meaning DMG in other parts of the brain such as the thalamus or spine) anytime after standard radiation OR after progression. This Arm also includes other recurrent/refractory CNS tumors.
Primary Outcome
Number and percent of subjects with sufficient therapeutic product generated to receive two courses on the intended dose regimen
Conditions Studied
Interventions
- BIOLOGICAL SC-CAR4BRAIN
Study Locations (1)
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-05-05 |
| Est. Completion | 2043-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05768880 still lists
NCT05768880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (46% lower).
The record links to 5 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 1 intervention - of which SC-CAR4BRAIN is the first listed.
NCT05768880 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05768880 about?
NCT05768880 is a clinical study titled "Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors". This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with SC-CAR4BRAIN, an autologous CD4+ and CD8+ T cells lentivirally transduced to express to express combinations of B7-H3, EGFR806, HER2, and IL13-zetakine chimeric antigen receptors (CAR). CAR T cells are deliver...
What is the current status of trial NCT05768880?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2023-05-05. Estimated completion is 2043-12-31.
What conditions does trial NCT05768880 study?
This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, Refractory Primary Malignant Central Nervous System Neoplasm, Recurrent CNS Tumor, Adult, Recurrent, CNS Tumor, Childhood.
What interventions are being tested in trial NCT05768880?
The interventions under investigation include: SC-CAR4BRAIN (BIOLOGICAL).
Who is sponsoring clinical trial NCT05768880?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05768880 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05768880's enrollment target sits among peer trials
72 12th of 28 higher than 17 of 28 other Diffuse Intrinsic Pontine Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Intrinsic Pontine Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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