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NCT07031765 · ClinicalTrials.gov registry record · Phase 1
Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma
A Phase 1 study of Ependymoma and Oligodendroglioma, sponsored by University of Florida.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07031765: Active Phase 1 study of Ependymoma and Oligodendroglioma, sponsored by University of Florida.
NCT07031765 is a Phase 1 study of Ependymoma and Oligodendroglioma that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 12 participants, below the 104-participant average among 20 other Ependymoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07031765, a Phase 1 study of Ependymoma and Oligodendroglioma, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is recurrent, progressive or refractory following radiotherapy with or without chemotherapy. Patients must be candidates for standard of care surgical resection or biopsy.
Primary Outcome
Rate of DLTs in participants treated with exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given.
Conditions Studied
Interventions
- DRUG Nivolumab
- BIOLOGICAL exHSC
- PROCEDURE Resection or biopsy
Study Locations (1)
Florida
- UF Health Shands Children's Hospital/Shands Hospital - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2032-12 |
| Phase | Phase 1 |
What the registry record for NCT07031765 still lists
NCT07031765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 104-participant average among 20 other Ependymoma trials with a reported enrollment target (88% lower).
The record links to 6 conditions, with Ependymoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT07031765 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07031765 about?
NCT07031765 is a clinical study titled "Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma". This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV astrocytoma, oligodendrogliomas, oligoastrocytomas, ependymomas) that is ...
What is the current status of trial NCT07031765?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-07-25. Estimated completion is 2032-12.
What conditions does trial NCT07031765 study?
This clinical trial studies the following conditions: Ependymoma, Oligodendroglioma, Recurrent High Grade Glioma, Oligoastrocytoma, Grade IV Astrocytoma.
What interventions are being tested in trial NCT07031765?
The interventions under investigation include: Nivolumab (DRUG), exHSC (BIOLOGICAL), Resection or biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT07031765?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07031765 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07031765's enrollment target sits among peer trials
12 18th of 20 higher than 2 of 20 other Ependymoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ependymoma 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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