{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"1.8","value":"1.58"},{"groupId":"OG001","lowerLimit":"2.9","upperLimit":"5.1","value":"3.96"},{"groupId":"OG002","lowerLimit":"2.6","upperLimit":"11.6","value":"7.90"},{"groupId":"OG003","lowerLimit":"3.3","upperLimit":"11.5","value":"4.87"},{"groupId":"OG004","lowerLimit":"15.7","upperLimit":"19.0","value":"17.35"},{"groupId":"OG005","lowerLimit":"5.5","upperLimit":"23.3","value":"11.60"},{"groupId":"OG006","lowerLimit":"18.7","upperLimit":"50.5","value":"22.15"},{"groupId":"OG007","lowerLimit":"29.8","upperLimit":"29.8","value":"29.80"},{"groupId":"OG008","lowerLimit":"0.8","upperLimit":"13.6","value":"3.65"},{"groupId":"OG009","lowerLimit":"25.3","upperLimit":"42.8","value":"34.05"},{"groupId":"OG010","lowerLimit":"3.1","upperLimit":"4.9","value":"3.49"},{"groupId":"OG011","lowerLimit":"4.5","upperLimit":"8.6","value":"6.91"},{"groupId":"OG012","lowerLimit":"3.1","upperLimit":"16.5","value":"13.20"},{"groupId":"OG013","lowerLimit":"14.9","upperLimit":"23.1","value":"19.00"},{"groupId":"OG014","lowerLimit":"1.4","upperLimit":"34.3","value":"12.56"},{"groupId":"OG015","lowerLimit":"1.7","upperLimit":"88.7","value":"15.10"},{"groupId":"OG016","lowerLimit":"9.4","upperLimit":"27.0","value":"11.85"}]}]}],"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 CD4+ Cells (10\\^9/L) = Ki-67+ Cells of CD4+ 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.","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+ CD4+ T Cells on Day 6 of Cycle 1","type":"SECONDARY","unitOfMeasure":"percentage of cells with activation"}