Clinical and immunological outcome
| Blood-derived DC treated patient~ | Measurable disease sites at baselinea | Radiological progression-free survival (mo)b | Overall survival(mo) | Dmc SKILse | IFN-γc SKILse | Number of vaccinations |
|---|---|---|---|---|---|---|
| mDC-01 | Bone | 23.6 | 36.1c | + | + | 9 |
| mDC-02 | – | 24.3c | 34.8c | + | + | 9 |
| mDC-03 | – | 24.8c | 34.8c | + | – | 9 |
| mDC-04 | LN, bone | 3.4 | 28.0 | + | – | 3 |
| mDC-05 | LN | 12.0 | 30.2c | + | + | 6 |
| mDC-06 | Bone | 3.4 | 23.3 | – | + | 3 |
| mDC-07 | LN, bone | 3.4 | 17.1 | + | – | 3 |
| pDC-01 | LN | 18.8 | 36.8c | + | + | 9 |
| pDC-02 | Bone | 6.4 | 24.9 | – | + | 6 |
| pDC-03 | LN, bone | 3.4 | 20.0 | – | – | 3 |
| pDC-04 | LN | 18.9 | 27.6c | + | – | 9 |
| pDC-05 | Bone | 6.1 | 27.6c | – | + | 6 |
| pDC-06 | LN | 23.9c | 37.8c | + | – | 9 |
| pDC-07 | LN, bone | 10.7d | 10.7 | + | – | 6 |
| combiDC-01 | Bone | 4.2 | 41.2c | – | – | 3 |
| combiDC-02 | Bone | 3.2 | 21.7 | + | – | 3 |
| combiDC-03 | – | 3.7 | 20.4 | + | – | 3 |
| combiDC-04 | Bone | 9.5 | 27.2c | + | – | 6 |
| combiDC-05 | Bone | 3.4 | 26.7c | – | – | 3 |
| combiDC-06 | LN, bone | 9.7 | 25.6c | + | – | 6 |
| combiDC-07 | LN, bone | 12.0 | 24.4c | + | + | 9 |
DC dendritic cells, Dm dextramer, LN lymph nodes, mo months, SKILs skin-infiltrating lymphocytes
ameasurable disease sites were determined on advanced imaging with contrast-enhanced 68Ga-prostate-specific membrane antigen (PSMA) PET/CT scans, for RECIST 1.1 and ferumoxtran-10-enhanced MRIs and MRI bones for PCWG2 criteria
bradiological responses were assessed on contrast-enhanced 68Ga-PSMA PET/CT scans, ferumoxtran-10-enhanced MRIs and MRI lymph nodes for RECIST 1.1 and MRI bones for PCWG2 criteria. In case of progressive disease according to RECIST 1.1 and/or PCWG2 criteria a confirmatory MRI lymph nodes and bones was performed 6–8 weeks later. The date used for calculation of progression-free survival was the first date at which progression criteria were met (the date of unconfirmed progression of disease)
cprogression-free survival or overall survival endpoint not reached in this patient
dpatient had stable disease according to RECIST 1.1 and PCWG2 criteria. At 10.7 months after apheresis patient deceased due to a ruptured type A acute aortic dissection
etetramer- or dextramer-positivity (dm+) or IFN-γ-positivity of SKILs if at least for one epitope CD8+ dm+ or IFN-γ+ T cells were detected