Clinical Trial

Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma

Study acronym: Peds CHAMP1ON
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-06-18; most recent amendment 2025-12-11.
Status change: Recruiting → Active, Not Recruiting 2025-12-11
Status change: Not Yet Recruiting → Recruiting 2025-07-25
Trial Details
NCT Number NCT07031765
Lead Sponsor University of Florida
Collaborators: Florida Department of Health
Conditions Recurrent High-grade Glioma, Grade III Astrocytoma, Oligodendroglioma, Oligoastrocytoma, Ependymoma, Grade IV Astrocytoma
Enrollment 12 participants
Start Date 2025-07-25
Primary Completion 2030-12 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-18