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

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

July 25, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2032

Conditions
Recurrent High-grade GliomaGrade III AstrocytomaOligodendrogliomaOligoastrocytomaEpendymomaGrade IV Astrocytoma
Interventions
BIOLOGICAL

exHSC

Ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) at a targeted dose of 2.5 x 106 cells/kg (or maximal achievable dose, with a minimum deliverable dose of 1/10 target dose; max dose 1.0 x 108 total cells for patients ≥40kg).

DRUG

Nivolumab

Nivolumab 3mg/kg once every 2 weeks, max dose 240mg. Nivolumab will be administered on day 1 and day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.

PROCEDURE

Resection or biopsy

Patients must be candidates for standard of care surgical resection or biopsy.

Trial Locations (1)

32608

RECRUITING

UF Health Shands Children's Hospital/Shands Hospital, Gainesville

All Listed Sponsors
collaborator

Florida Department of Health

OTHER_GOV

lead

University of Florida

OTHER