{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.","groups":[{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \\<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.","id":"OG000","title":"Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)"},{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \\<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.","id":"OG001","title":"Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)"},{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.","id":"OG002","title":"Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who received the planned TCR-T cell infusion and either experienced a DLT or completed the 28-day DLT observation period; those with major protocol deviations unrelated to safety during this period were considered non-evaluable.","reportingStatus":"POSTED","timeFrame":"From Day 0 to Day 28 post TCR-T cell drug product infusion.","title":"Frequency of Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}