NCT07031765

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 4 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with recurrent high-grade glioma. One cycle will be 28 days in length with exHSCs + Nivolumab being administered on day 1 and Nivolumab alone being administered on 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. There are two arms: Arm 1 - Immediate maximal surgical resection or biopsy, untreated tumor. exHSCs and Nivolumab will be administered after maximal surgical resection. Arm 2 - exHSCs + Nivolumab will be administered prior to maximal surgical resection or biopsy. exHSCs + Nivolumab will be administered after surgery.

Conditions

• Recurrent High-grade Glioma
• Grade III Astrocytoma
• Oligodendroglioma
• Oligoastrocytoma
• Ependymoma
• Grade IV Astrocytoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-25
• Primary completion: 2030-12-01
• Completion: 2032-12-01
• First posted: 2025-06-22
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study