12
Participants
Start Date
May 5, 2025
Primary Completion Date
September 1, 2027
Study Completion Date
December 1, 2028
TTRNA-DC vaccines with GM-CSF
"After chemoradiation subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. Monthly DC vaccines will be given during TMZ Cycles 2-5 for Groups A and B and 48-96 hours after completion of TMZ Cycle 6 Day 21 for Group A and 12-36 hours after HSCs for Group B. All subjects will receive an additional two bi-weekly vaccines during Cycle 6 for a total of 10 DC vaccines. All DC vaccines will be embedded with GM-CSF (150 µg per injection) and given intradermal.~up to 9 intradermal DC vaccines (three -bi-weekly (q2 weeks) for priming, monthly for additional 2-3 cycles during T cell expansion, and three bi-weekly during T cell engraftment)"
TTRNA-xALT
All participants will receive a single infusion of T-cells.
Td vaccine
A full Td booster vaccine will be administered IM at Vaccine #1 to all subjects, and vaccine site pretreatment will be administered to all subjects prior to Vaccine#3, #5, #7 and #9.
autologous HSCs
All participants will receive a single intravenous infusion of autologous HSCs.
Pembrolizumab
Participants will receive PD-1 blockade IV starting with ACT continuing for up to 2 years as long as tolerable and without disease progression.
RECRUITING
University of Florida Health, Gainesville
Collaborators (1)
Children's National Research Institute
OTHER
University of Florida
OTHER