Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
Study NCT ID:
NCT06019702
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Study Overview
Official Title:
A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Status:
RECRUITING
Status Verified Date:
2023-09
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 purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.
Detailed Description:
This is a multi-part single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 monotherapy in subjects with advanced digestive system neoplasms. The study will include a dose escalation phase and dose expansion phase. The traditional 3+3 design will be used in dose escalation.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: