drugset / Trial / NCT07031765

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

NCT07031765 ↗

Phase 1 Active not recruiting 12 enrolled University of Florida Florida Department of Health · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-25
Primary completion
2030-12
Completion
2032-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 3 mg/kg —
Subject exHSC Cell therapy 2.5 cells/kg —