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ACTIVE NOT RECRUITING
NCT06514898
PHASE1

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

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

This is a pilot study in a small number of children and young adults with suspected recurrent/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.

Official title: MATCHPOINT - Medulloblastoma Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade

Key Details

Gender

All

Age Range

4 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-05-05

Completion Date

2028-12-01

Last Updated

2026-04-03

Healthy Volunteers

No

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.

Locations (1)

University of Florida Health

Gainesville, Florida, United States