{"classes":[{"categories":[{"measurements":[{"comment":"The MTD or RP2D could not be determined because the study closed early before sufficient participants were treated and evaluated for DLTs to allow formal determination.","groupId":"OG000","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.","groups":[{"description":"Includes all participants who received a TCR-T cell infusion and were monitored for DLTs across all dose levels (6 participants at Dose Level 1 and 2 participants at Dose Level 2; total = 8).","id":"OG000","title":"All Dose Levels (DLT-Evaluable Population)"}],"paramType":"NUMBER","populationDescription":"All participants who received a TCR-T infusion and were monitored for DLTs were included in a single analysis population. Eight participants were infused (6 at Dose Level 1, 2 at Dose Level 2). The MTD/RP2D could not be determined because the study closed early before enough evaluable participants were treated to allow formal determination.","reportingStatus":"POSTED","timeFrame":"From Day 0 to Day 28 post TCR-T cell drug product infusion.","title":"Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)","type":"PRIMARY","unitOfMeasure":"Dose level of TCR-T cells infused"}