Single-Patient Expanded Access Protocol - RNA-LP in a Pat... | NCT07560709

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

NCT07560709

Sponsor

University of Florida

Status

No longer available

Last Update Posted

May 1, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Recurrent Osteosarcoma

Interventions

pp65/tumor mRNA RNA-LP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 21, 2026

First Posted Date

May 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

May 1, 2026Actual

Description Module

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.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pp65/tumor mRNA RNA-LP	Biological	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)		RNA loaded lipid particles, RNA-LPs

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Individual patient expanded access protocol

Minimum Age

15 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Health		Gainesville	Florida	32608	United States

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided