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Clinical Trials/NCT07560709
NCT07560709No Longer AvailableNot Applicable

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

University of Florida1 site in 1 countryStarted: May 1, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
No Longer Available
Locations
1
Study OverviewEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
15 Years to 17 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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