Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477614
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-22
Brief Title:
Anti-cancer DC Cell Vaccination to Treat Solid Tumors
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Anti-cancer DC Cell Vaccination to Treat Advanced Solid Tumors Phase I Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Placental or tumor-derived heat shock protein gp96 is collected purified and stored The DC cells are isolated from the patients blood and then cocultured with the gp96 to obtain the activated DC cell product The manufactured DC cells are subcutaneously or intra-tumor injected into the patient Clinical studies will be performed to test anti-cancer function of the DC vaccination for immunotherapy of cancer patients In this phase I study the safety tolerance and preliminary efficacy of the DC vaccine immunotherapy on advanced cancers will firstly be evaluated
Detailed Description:
1 Choose appropriate patients with advanced solid cancers with written consent for this study
2 Perform biopsy to get fresh sample for generation gp96 protein Collect DC cells from the cancer patient
3 Produce appropriate DC cell vaccine and deliver the vaccine into selected patients via local injections and follow up closely to collect related results as required
4 To enhance the killing capability cotreatment the patients with vaccine aduvants or PD1PDL1CTLA4 antibodies may be applied
5 Evaluate the clinical results as needed
2 Perform biopsy to get fresh sample for generation gp96 protein Collect DC cells from the cancer patient
3 Produce appropriate DC cell vaccine and deliver the vaccine into selected patients via local injections and follow up closely to collect related results as required
4 To enhance the killing capability cotreatment the patients with vaccine aduvants or PD1PDL1CTLA4 antibodies may be applied
5 Evaluate the clinical results as needed
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