Solid Tumor Clinical Trial
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
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.
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. ;
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