RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
United States24 participantsStarted 2024-12-02
Plain-language summary
This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>/= 18years
* Histopathologically proven GBM using the 2021 WHO Classification of Tumors of the CNS (WHO CNS5).
* Unequivocal evidence of tumor progression as documented by brain MRI scan per RANO criteria.
* Tumor must have a primary supratentorial component at the time of disease progression.
* Patients must have received surgery and completed Fractionated Radiation therapy as frontline treatment for primary disease, either alone or with concurrent therapy (including temozolomide or another systemic chemotherapy agent). Patients must be at least 12 weeks post chemoradiation completion.
* Patient must be at least 90 days from completion of prior radiation
* Any adverse events patient has experienced from prior therapy must have resolved to ≤ Gr. 1 according to CTCAE (NCI Common Terminology Criteria for Adverse Events) v5.0 prior to enrollment
* Patient must be either weaned off steroids or weaned onto physiologic dosing at the time of enrollment.
* Patient must be a candidate for surgery/biopsy as acceptable standard of care for sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).
* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment.
* Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchai…
What they're measuring
1
Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines
Timeframe: from the date of surgery until administration of third vaccine, up to 20 weeks
2
Incidence of investigational treatment related toxicities
Timeframe: from first vaccine to 30 days after last dose of vaccine administered, up to 17 months