Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141369
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-11-13
Brief Title:
Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine mRNA-0523-L001
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine mRNA-0523-L001
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Treatment of advanced endocrine tumors including adrenal corticocarcnioma ACC medullary thyroid carcinoma MTC thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging Previous genomic profiling studies showed they presented a number of somatic mutations The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine mRNA-0523-L001 for the treatment of advanced endocrine tumors failure of standard treatment or no standard treatment currently available The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors failure of standard treatment or no standard treatment currently available including
1 Neoantigen-specific CD4 and CD8 T lymphocyte responses induced by mRNA-0523-L001
2 Objective response rate ORR and disease control rate DCR of tumors
3 Progression-free survival PFS
1 Neoantigen-specific CD4 and CD8 T lymphocyte responses induced by mRNA-0523-L001
2 Objective response rate ORR and disease control rate DCR of tumors
3 Progression-free survival PFS
Detailed Description:
None
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?:
None