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

Conditions

• Recurrent Group 3 Medulloblastoma
• Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma

Eligibility Criteria

Sex

ALL

Age

4 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• TTRNA-DC vaccines with GM-CSF — BIOLOGICAL
  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 — BIOLOGICAL
  All participants will receive a single infusion of T-cells.
• Td vaccine — DRUG
  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 — BIOLOGICAL
  All participants will receive a single intravenous infusion of autologous HSCs.
• Pembrolizumab — DRUG
  Participants will receive PD-1 blockade IV starting with ACT continuing for up to 2 years as long as tolerable and without disease progression.

Study Details

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.

Key Dates

Start date

May 5, 2025

Status verified

Jun 2026

Primary completion

Sep 1, 2027

Completion

Dec 1, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Adoptive Cellular Therapy (ACT) + PD-1 blockade with pembrolizumab
  ACT + PD-1 blockade consists of the intravenous delivery of ex vivo expanded tumor-reactive lymphocytes and autologous hematopoietic stem cells (HSCs) with concomitant tumor RNA-pulsed DC vaccines followed by intravenous delivery of PD-1 blocking antibodies.

Primary Outcome Measure

Number of participants with immunotherapy-related dose-limiting toxicities after treatment with TTRNA-DCs, TTRNA-xALT and HSCs plus PD1 blockade [ Time Frame: enrollment to completion of DLT window; up to 12 months ]

Central Contacts

• Marcia Hodik, RN
  352-273-6971
  [email protected]

Locations (1)

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