{"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":"FG000","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":"FG001","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":"FG002","title":"Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Apheresed but not administered TCR-T cells due to manufacturing failure"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Apheresed but not administered TCR-T cells due to participant developed brain metastases"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Apheresed but not administered TCR-T cells due to early termination of study"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Cells manufactured but not infused due to participant cerebrovascular accident"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"type":"Apheresis 1"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Apheresis 2"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"0"}],"type":"Manufacture 1"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Manufacture 2"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lymphodepletion (Enrollment)"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"TCR Infusion"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Assigned Dose Level 2 But Received Dose Level 1 Due to Manufacturing Process"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 14 participants underwent apheresis. Per protocol, participants were considered enrolled upon meeting lymphodepletion criteria (n = 8). Six participants were not dosed due to manufacturing failure (n = 2), clinical deterioration (n = 1), or study closure prior to dosing (n = 3). BOIN accelerated dose escalation began with 1 subject at Dose Level 1; additional participants could be enrolled at safe dose levels based on manufactured cell count.","recruitmentDetails":"34 participants signed consent forms, 14 participants were apheresed, and 8 participants were lymphodepleted and per the protocol definition were considered enrolled. 8 were treated with TCR-T cells."}