Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03707808
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2018-02-05
Brief Title:
Intratumoral Injection of Autologous CD1c BDCA-1 myDC Avelumab and Ipilimumab Plus Systemic Nivolumab
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Phase I Clinical Trial on Intratumoral Administration of Autologous CD1c BDCA-1 Myeloid Dendritic Cells Plus Avelumab and Ipilimumab in Combination With Intravenously Administered Nivolumab
Status:
COMPLETED
Status Verified Date:
2020-12
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:
myDAvIpNi
Brief Summary:
This phase I trial aims at investigating a new combinatorial immunotherapy regimen using intratumoral injection of autologous CD1c BDCA-1 myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody mAb ipilimumab and the PD-L1 blocking mAb avelumab Concomitantly nivolumab a PD-1 blocking mAb will be administered intravenously
Detailed Description:
This phase I trial aims at investigating a new combinatorial immunotherapy regimen using intratumoral injection of autologous CD1c BDCA-1 myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody mAb ipilimumab and the PD-L1 blocking mAb avelumab Concomitantly nivolumab a PD-1 blocking mAb will be administered intravenously
CD1c BDCA-1 myeloid dendritic myDC cells will be obtained by immunomagnetic isolation from PBMC obtained by leukapheresis The CD1c BDCA-1 myDC will not be substantially manipulated prior to autologous intratumoral injection immediately following the isolation and concentration isolation and administration will be performed in the same procedure The investigators consider that the isolation represents a non-substantial manipulation of this somatic cell therapy product The intended use of CD1c BDCA-1 myDC in this clinical protocol is to enrich their presence within the injected metastasis where they should execute their physiological role of coordinating the anti-tumor immune response Based on recent preclinical data absence of myeloid dendritic cells in the tumor microenvironment is an important immune escape mechanism of malignant tumors
CD1c BDCA-1 myeloid dendritic myDC cells will be obtained by immunomagnetic isolation from PBMC obtained by leukapheresis The CD1c BDCA-1 myDC will not be substantially manipulated prior to autologous intratumoral injection immediately following the isolation and concentration isolation and administration will be performed in the same procedure The investigators consider that the isolation represents a non-substantial manipulation of this somatic cell therapy product The intended use of CD1c BDCA-1 myDC in this clinical protocol is to enrich their presence within the injected metastasis where they should execute their physiological role of coordinating the anti-tumor immune response Based on recent preclinical data absence of myeloid dendritic cells in the tumor microenvironment is an important immune escape mechanism of malignant tumors
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