{"groups":[{"description":"Participants who received afamitresgene autoleucel 0.1x10\\^9 (±20%) transduced cells","id":"FG000","title":"Afamitresgene Autoleucel, Group 1"},{"description":"Participants who received afamitresgene autoleucel 0.5-1.2x10\\^9 transduced cells","id":"FG001","title":"Afamitresgene Autoleucel, Group 2"},{"description":"Participants who received afamitresgene autoleucel 1.2-10x10\\^9 transduced cells","id":"FG002","title":"Afamitresgene Autoleucel, Group 3 + Expansion"},{"description":"Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\\^9 transduced cells).","id":"FG003","title":"Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"}],"type":"Ongoing in Interventional phase at data cut-off (1Sep2020)"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"32"},{"groupId":"FG003","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"32"},{"groupId":"FG003","numSubjects":"4"}],"type":"Received Afamitresgene Autoleucel"},{"achievements":[{"comment":"1completed = discontinued from the Interventional phase","groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The main study could enroll up to 18 participants in the dose escalation phase (data cut off 01Sep2020). Following the dose escalation phase, the study was expanded to enroll up to approximately 30 participants at the selected dose range (inclusive of those treated during dose escalation at that dose range) across all the eligible tumor types to better characterize and assess overall safety. The sub study planned to enroll up to 10 participants (data cut off 13Jan2022).","recruitmentDetails":"This was an open-label Phase 1 dose escalation study of afamitresgene autoleucel in HLA-A\\*02 positive participants with MAGE-A4 expressing unresectable locally advanced or metastatic cancer of the following types: urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal (squamous and adenocarcinoma), gastric, synovial sarcoma, or MRCLS. This study had a substudy component that investigated the safety and tolerability of afamitresgene autoleucel in combination with low dose radiation."}