{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Hypoxia-Grade 4- Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Respiratory Failure-Grade 4- Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Hypotension-Grade 4-Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Acute Kidney Injury- Grade 4- Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Delirium-Grade 3-Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Dysphagia-Grade 3-Serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Acidosis- Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Hyperkalemia-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Alanine aminotransferase increased-Grade 4-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Alanine aminotransferase increased-Grade 3- Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Aspartate aminotransferase increased-Grade 4-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Aspartate aminotransferase increased-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"CPK increased-Grade 4-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"CPK increased-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Blood bilirubin increased-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Acute kidney injury-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Peripheral ischemia-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Anxiety-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Hypophosphatemia-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Generalized muscle weakness-Grade 3-Non-serious"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Hypokalemia-Grade 3-Non-serious"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"Adverse events were assessed by the Common Terminology Criteria for Adverse Events v4.0. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A DLT is defined as all Grade 3 and greater toxicities occurring within 30 days of the cell infusion with the exception of: Cytokine Release Syndrome (CRS) that resolves ≤ grade 2 within 14 days of the last dose of aldesleukin. Autoimmune toxicity that resolves to ≤ grade 2 within 14 days for starting symptom treatment (e.g. steroids). Cardiac, gastrointestinal, dermatological, hepatic, pulmonary, renal, hematologic, neurologic toxicity, or toxicity in Appendix C of the protocol attributable to aldesleukin that resolves to ≤ grade 2 within 14 days of the last dose of aldesleukin. Transient grade 3 hypoxia associated with cell infusion that corrects to ≤ grade 2 with supplemental oxygen and/or that resolves to ≤ grade 2 within 24 hours or before starting aldesleukin.","groups":[{"description":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.","id":"OG000","title":"Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells"},{"description":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.","id":"OG001","title":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells"},{"description":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.","id":"OG002","title":"Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells"}],"paramType":"NUMBER","populationDescription":"194/224 participants enrolled but not treated were not evaluable.","reportingStatus":"POSTED","timeFrame":"From the day of cell infusion (Day 0) to Day +30","title":"Phase I: Number of Dose Limiting Toxicities (DLT)","type":"PRIMARY","unitOfMeasure":"toxicities"}