{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Unable to be apheresed for logistical or medical reasons"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Apheresis performed but manufacturing not initiated due to study closure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Product was successfully manufactured but not administered due to progression or comorbidity."},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Infused successfully at the planned dose after 1 manufacturing round."},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Infused at a lower dose than planned after 1 manufacturing round."},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Infused at a lower dose than planned after 2 manufacturing rounds."},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Patients who were manufacturing failures after 2 manufacturing rounds."},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Product was successfully manufactured but not administered due to study closure."}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"description":"Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.","groups":[{"description":"Includes all 14 participants who underwent apheresis with intent to manufacture TCR-T cell drug product. Although only 8 met criteria for lymphodepletion and were considered enrolled per protocol, all 14 were included for assessment of manufacturing feasibility.","id":"OG000","title":"Apheresed Participants (Feasibility Population)"}],"paramType":"NUMBER","populationDescription":"The feasibility analysis included 14 participants who underwent apheresis with intent to manufacture TCR-T cell product. Although only 8 met criteria for lymphodepletion and were considered formally enrolled per protocol, all 14 apheresed participants were included for feasibility assessment because manufacturing could be attempted for each.","reportingStatus":"POSTED","timeFrame":"From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks","title":"Feasibility of TCR-T Cell Drug Product Manufacturing","type":"SECONDARY","unitOfMeasure":"participants"}