{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}],"units":"Participants"}],"description":"Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration.\n\nThe count of patients not meeting the preparation criteria are reported.","groups":[{"description":"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.\n\nCyclophosphamide: Given IV at 1 x 10\\^7\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeukapheresis: Undergo leukapheresis\n\nTGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV","id":"OG000","title":"Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)"},{"description":"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.\n\nCyclophosphamide: Given IV at 1 x 10\\^8\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeukapheresis: Undergo leukapheresis\n\nTGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV","id":"OG001","title":"Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)"},{"description":"Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.\n\nCyclophosphamide: Given IV at 1 x 10\\^9\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeukapheresis: Undergo leukapheresis\n\nTGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV","id":"OG002","title":"Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)"},{"description":"Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.\n\nCyclophosphamide: Given IV at 1 x 10\\^9\n\nDecitabine: Given IV at 20 mg/m\\^2 x 3 days\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeukapheresis: Undergo leukapheresis","id":"OG003","title":"Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"1 month","title":"Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells","type":"PRIMARY","unitOfMeasure":"Participants"}