12
Participants
Start Date
July 25, 2025
Primary Completion Date
December 31, 2030
Study Completion Date
December 31, 2032
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).
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.
Resection or biopsy
Patients must be candidates for standard of care surgical resection or biopsy.
RECRUITING
UF Health Shands Children's Hospital/Shands Hospital, Gainesville
Florida Department of Health
OTHER_GOV
University of Florida
OTHER