Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

December 1, 2028

Conditions
Recurrent Group 3 MedulloblastomaRecurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
Interventions
BIOLOGICAL

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)"

BIOLOGICAL

TTRNA-xALT

All participants will receive a single infusion of T-cells.

DRUG

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.

BIOLOGICAL

autologous HSCs

All participants will receive a single intravenous infusion of autologous HSCs.

DRUG

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.

Trial Locations (1)

32608

RECRUITING

University of Florida Health, Gainesville

All Listed Sponsors
collaborator

Children's National Research Institute

OTHER

lead

University of Florida

OTHER