Immunogene therapy
The GMP production of dendritic cells (DC) from peripheral blood has been established at the Lab. for Cellular Therapy. Two clinical phase I/II vaccine trials are ongoing; vaccinating with mRNA transfected autologous dendritic cells. In the melanoma patients, mRNA is extracted from patients` tumour and in the case of prostate cancer patients, the mRNA is extracted from three established prostate cancer cell lines. To optimise the DC delivery, the dendritic cells which initially were injected subcutaneously, are now being injected directly into the lymph node cortex under ultrasound guidance.
Main objectives for these studies are safety and immunologic response. Current status for the various trials is as follows:
Main objectives for these studies are safety and immunologic response. Current status for the various trials is as follows:
- Phase II trial with antisense oligonucleotides directed against PKC-alfa in-patients with advanced malignant melanoma (closed, multicenter trial, 3 patients included).
- Phase II trial with antisense directed against PKC-alfa in patients with advanced non-small cell lung cancer (closed, multi-centre trial, 3 patients included).
- Phase III trial with adeno-virus transfected with wild type P-53 to patients with advanced ovarian carcinoma (closed, the study was approved by the authorities, over 100 patients were screened, but none were included in the trial).
- Phase I/II trial in malignant melanoma patients with dendritic cells transfected with mRNA from patients tumour (open, single institution trial, 19 patients included).
- Phase I/II trial in patients with prostate cancer with dendritic cells transfected with mRNA from three different cell lines (open, single institution trial, 6 patients included).
- Phase III trial antisense oligonucleotides directed against PKC-alfa plus gemcitabine and cisplatin versus gemcitabine and cisplatin in non-small cell lung cancer patients (open, multicenter trial, 6 patients included.