Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05660408
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2022-12-13
Brief Title:
Study of RNA-lipid Particle RNA-LP Vaccines for Recurrent Pulmonary Osteosarcoma OSA
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Study of RNA-lipid Particle RNA-LP Vaccines for Recurrent Pulmonary Osteosarcoma OSA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators have shown that intravenous administration of tumor mRNA loaded lipid particles LPs localizes primarily to lung transfect antigen presenting cells APCs and lead to an activated T cell response for induction of anti-tumor immunity In contrast to other formulations RNA-LPs recruit multiple arms of the immune system ie innateadaptive and remodel the systemicintratumoral immune milieu which remain potent barriers for vaccine cellular and checkpoint inhibiting immunotherapies After only a single RNA-LP vaccine the bulk of systemic and intratumoral dendritic cells DCs in mice display an activated phenotype these activated DCs harvested from tumors expand antigen specific T cell immunity In immunologically resistant pulmonary osteosacroma murine tumor models ie K7M2 RNA-LPs induce robust anti-tumor efficacy in settings where immune checkpoint inhibitors ie anti-PD-L1 therapy do not confer therapeutic benefit We have already demonstrated safety of RNA-LPs in acutechronic murine toxicity studies and in client-owned canine trial
In this study we will investigate the safety and immunologic activity of RNA-LP vaccine in patients with recurrent pulmonary osteosarcoma
In this study we will investigate the safety and immunologic activity of RNA-LP vaccine in patients with recurrent pulmonary osteosarcoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCR43060 | OTHER | University of Florida | None |