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Single-Patient Expanded Access Protocol - RNA-LP in a Patient With Recurrent Osteosarcoma

Single-Patient Expanded Access Treatment Protocol for Use of RNA Loaded Lipid Particles (RNA-LPs) in a Patient With Recurrent Osteosarcoma

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT07560709
Enrollment
Unknown
Registered
2026-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Osteosarcoma

Brief summary

Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.

Detailed description

The prognosis for patients with recurrent osteosarcoma and measurable disease is dismal and there are no FDA-approved therapies for this indication. A patient was enrolled on a clinical trial to develop a personalized pp65/tumor mRNA RNA-LP; however, the patient progressed following pp65 RNA-LP and had to be taken off treatment. Because the patient had not yet received personalized pp65/tumor mRNA RNA-LP, the IND sponsor treated the patient under an expanded access, individual patient protocol.

Interventions

BIOLOGICALpp65/tumor mRNA RNA-LP

Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)

Sponsors

University of Florida
Lead SponsorOTHER

Eligibility

Sex/Gender
MALE
Age
15 Years to 17 Years

Inclusion criteria

* Participated in clinical trial * Received pp65 RNA-LPs alone and had pp65/tumor mRNA RNA-LP manufactured * Progressive disease prior to treatment with pp65/tumor mRNA RNA-LP

Exclusion criteria

• Diagnosis of recurrent OSA is not histopathologically confirmed (i.e. pseudoprogression)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026