{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.5","upperLimit":"3.8","value":"3.13"},{"groupId":"OG001","lowerLimit":"10.4","upperLimit":"30.2","value":"15.40"},{"groupId":"OG002","lowerLimit":"21.2","upperLimit":"28.5","value":"24.10"},{"groupId":"OG003","lowerLimit":"16.8","upperLimit":"44.3","value":"27.50"},{"groupId":"OG004","lowerLimit":"39.5","upperLimit":"50.8","value":"45.15"},{"groupId":"OG005","lowerLimit":"24.9","upperLimit":"76.9","value":"34.85"},{"groupId":"OG006","lowerLimit":"64.6","upperLimit":"82.1","value":"76.85"},{"groupId":"OG007","lowerLimit":"72.0","upperLimit":"72.0","value":"72.00"},{"groupId":"OG008","lowerLimit":"1.0","upperLimit":"82.1","value":"17.41"},{"groupId":"OG009","lowerLimit":"42.0","upperLimit":"91.3","value":"66.65"},{"groupId":"OG010","lowerLimit":"10.9","upperLimit":"21.8","value":"21.00"},{"groupId":"OG011","lowerLimit":"16.8","upperLimit":"30.3","value":"21.00"},{"groupId":"OG012","lowerLimit":"14.2","upperLimit":"73.9","value":"56.30"},{"groupId":"OG013","lowerLimit":"53.6","upperLimit":"63.1","value":"58.35"},{"groupId":"OG014","lowerLimit":"2.1","upperLimit":"78.5","value":"43.75"},{"groupId":"OG015","lowerLimit":"6.1","upperLimit":"95.9","value":"53.90"},{"groupId":"OG016","lowerLimit":"41.2","upperLimit":"81.6","value":"63.35"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"4"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"15"},{"groupId":"OG016","value":"4"}],"units":"Participants"}],"description":"The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation:\n\n* Ki-67+ Cells of CD8+ Cells (10\\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC\n* CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (10\\^9/L) = CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.\n\nAbsolute count of CD45RO+ CD45RA- (Memory) Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.","dispersionType":"Full Range","groups":[{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG000","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG001","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG002","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG003","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG004","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG005","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG006","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG007","title":"Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG008","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.","id":"OG009","title":"Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG010","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG011","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG012","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG013","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.\n\nPembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG014","title":"Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","id":"OG015","title":"Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.","id":"OG016","title":"Part B1 (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg"}],"paramType":"MEDIAN","populationDescription":"For several patients the PD profile was not evaluable: 7 patients in part A (1 in 0.25 μg/kg, 1 in 6 μg/kg, 2 in12 μg/kg and 3 in 15 μg/kg arms), 2 patients in Part A1 (1 in 9 μg/kg and 1 in 12 μg/kg arms), 5 patients in Part B (3 in 6 μg/kg, 1 in 9 μg/kg, and 1 in 12 μg/kg arm), and 37 patients in Part D.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 6","title":"Overall Activation Levels of Ki-67+ CD8+ CD45RO+ CD45RA- T Cells on Day 6 of Cycle 1","type":"SECONDARY","unitOfMeasure":"percentage of cells with activation"}