TREATMENT DEFINITIONS. 7.5.1 LEUKAPHERESIS AND BLOOD DRAW Prior to beginning CaPVax immunotherapy, patients are leukapheresed at the Apheresis Unit of the study center. Another leukapheresis may be performed between the first and fourth treatments depending on the DC yield from the first leukapheresis. Prior to each leukapheresis, a blood work-up is done at the study center to include CBC, platelet count, and Chem-22. Blood is drawn for immune monitoring prior to the CaPVax injections and on follow-up at weeks 14, 20, and 26. The blood is shipped to the sponsor.
7.5.2 CAPVAX INJECTIONS Five, ten, or twenty million mature, autologous rPSMA-loaded DC are injected intradermally in a shaved, clean area of the thigh. The CaPVax injections are given in alternating thighs once every month (26-32 days) for a total of 4 treatment cycles. Mature DC are defined as CD11c positive, CD14 negative cells as determined using flow cytometry. The percentage of CD14 positive cells varies from patient to patient and thus requires an adjustment in the number and volume of cells injected to achieve the originally planned dose of DC. The following is an example of how the injection volume is determined: FORMULA FOR CALCULATING INJECTION VOLUME: Cell count per vial / 0.25mL = Cells per mL Dose to be administered / Percent CD14 negative, CD11c positive cells = cell number to inject Cell number to Inject / cells per mL = Injection volume FOR EXAMPLE: If the cell count per vial is 10 x 10(6) and the percent CD14 negative, CD11c positive cells is 67%, and the dose to be administered is 10 x 10(6) cells, THEN:
