Recurrent OsteosarcomaNCT07560709
Single-Patient Expanded Access Protocol - RNA-LP in a Patient With Recurrent Osteosarcoma
A study testing pp65/tumor mRNA RNA-LP in people with Recurrent Osteosarcoma, run by University of Florida at 1 site in United States.
Trial summary
Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol. Read more about this study
- Who is it for?
- Ages 15 to 17 years, men only
- Conditions the study is for
- Recurrent Osteosarcoma
- What is being tested?
- pp65/tumor mRNA RNA-LP
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Men only
- Child
Who may be able to join
- 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
Who cannot join
- Diagnosis of recurrent OSA is not histopathologically confirmed (i.e. pseudoprogression)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health
Gainesville, Florida, 32608
About this study
Official title: Single-Patient Expanded Access Treatment Protocol for Use of RNA Loaded Lipid Particles (RNA-LPs) in a Patient With Recurrent Osteosarcoma
Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.
Read the 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.
- Conditions
- Recurrent Osteosarcoma
- Being tested
- pp65/tumor mRNA RNA-LP
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pp65/tumor mRNA RNA-LPBiological
Also called RNA loaded lipid particles, RNA-LPs
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent OsteosarcomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560709
- Sponsor's protocol ID
- IRB202600515
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Patient Expanded Access Treatment Protocol for Use of RNA Loaded Lipid Particles (RNA-LPs) in a Patient With Recurrent Osteosarcoma
- ClinicalTrials.gov ID
- NCT07560709
- Acronym / sponsor ID
- IRB202600515
- Conditions
- Recurrent Osteosarcoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of FloridaUniversity, hospital or other
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Male only
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of recurrent OSA is not histopathologically confirmed (i.e. pseudoprogression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pp65/tumor mRNA RNA-LPAlso: RNA loaded lipid particles, RNA-LPsAutologous 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) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pp65/tumor mRNA RNA-LP in people with Recurrent Osteosarcoma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.