(A) Adoptive transfer of re-directed T cells: (1) 250 ml blood withdrawal at day −21, (2) separation of CD8+ T cells, (3) retroviral transduction of the CAR (+) specific for FAP, (4) adoptive transfer of re-directed T cells day 0. (B) Study course: As concomitant palliative therapy chemotherapy with cycles of 21 days will be given before and after adoptive transfer. Re-directed T cells will be given 14 days after third cycle of palliative chemotherapy into the pleural effusion. Blood draw of 250 ml blood will be performed at day −21 for the production or re-directed T cells. Patients will be continuously monitored at an intermediate care unit (ICU) for the first 48h after the adoptive transfer of re-directed T cells into the pleural effusion (day 0). 30 min before the application of the re-directed T cells 16 mg Dexamethason will be given i.v. as pre-medication. The fourth cycle of palliative chemotherapy will be started 14 days after transfer. Palliative chemotherapy is not part of the study protocol. Radiation therapy is not permitted. Pleurodesis is not allowed until completion of the study. Supportive or other palliative measures are permitted without any exceptions. (C) CT scan of the thorax of a patient with MPM. The tumor nodules are attached to the pleural causing pleural effusion. The schematic syringe represents the application of the re-directed T cells in the pleural infusion resulting in a proximity of re-directed T cells and tumor.
Petrausch et al. BMC Cancer 2012 12:615 doi:10.1186/1471-2407-12-615