RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
United States24 participantsStarted 2026-05-15
Plain-language summary
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent/progressive Medulloblastoma (MB)
Who can participate
Age range4 Years – 39 Years
SexALL
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Inclusion Criteria:
* Age \> 3 and \</= 39 years.
* Histologically confirmed or suspected recurrent/progressive MB in first or second relapse.
* Patients must have received radiation therapy as part of prior therapy.
* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).
* Prior Therapy: Patients must have fully recovered from all acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
* XRT/External Beam Irradiation, including Protons: ≥ 90 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis.
* Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above.
* Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.
* A diagnostic contrast-enhanced MRI of the brain and spine must be performed preoperatively, and diagnostic contrast-enhanced MRI of the area biopsied or resected must be performed postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days aft…
What they're measuring
1
Manufacturing feasibility
Timeframe: from the date of surgery until administration of third vaccine, up to 15 weeks
2
Safety of RNA-LP vaccine
Timeframe: First vaccine through 14 days after administration of the 3rd vaccine