Ignite Creation Date:
2025-12-18 @ 9:19 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT06751940
Status:
None
Last Update Posted:
2024-12-30 00:00:00
First Post:
2024-12-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoantigen-loaded DC Vaccine and Conventional Second-line Therapy for CRC Progressed After First-line Treatment
Sponsor:
None
Organization:
Study Overview
Official Title:
A Multicenter Clinical Study of Personalized Tumor Neoantigen-loaded DC Vaccine Combined with Conventional Second-line Therapy for the Treatment of Colorectal Cancer Progressed After First-line Treatment
Status:
None
Status Verified Date:
2024-12
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:
This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
10 patients with CRC progressed after first-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional second-line therapy and personalized tumor neoantigen-loaded DC vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-loaded DC vaccine:
Collecting venous blood samples; Blood PBMC exome sequencing; RNA transcriptome sequencing; Classifying HLA alleles; Performing bioinformatics analysis, finding meaningful mutations and about 20 neoantigen sequences for each patient; Synthesizing neoantigens; Use a blood apheresis device to collect the patient's blood, isolate the PBMC needed to prepare DC cells, and return the remaining blood components to the patient's body (approximately 10\^9 cells will be collected);Preparation of the personalized tumor neoantigen-loaded DC vaccine.
Participants will receive a conventional second-line therapy course and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. After treatment, participants will be followed in every 6 weeks till the end of the study. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
10 patients with CRC progressed after first-line therapy will be recruited in this study. With doctor's assessment, a combined treatment of conventional second-line therapy and personalized tumor neoantigen-loaded DC vaccine treatment plan will be designed for each participant.
Here are the steps for preparing the neoantigen-loaded DC vaccine:
Collecting venous blood samples; Blood PBMC exome sequencing; RNA transcriptome sequencing; Classifying HLA alleles; Performing bioinformatics analysis, finding meaningful mutations and about 20 neoantigen sequences for each patient; Synthesizing neoantigens; Use a blood apheresis device to collect the patient's blood, isolate the PBMC needed to prepare DC cells, and return the remaining blood components to the patient's body (approximately 10\^9 cells will be collected);Preparation of the personalized tumor neoantigen-loaded DC vaccine.
Participants will receive a conventional second-line therapy course and 10 subcutaneous injections of the vaccine within a treatment period of 21 weeks. After treatment, participants will be followed in every 6 weeks till the end of the study. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: