{"entity":{"id":"ignyte-eso","kind":"trial","name":"IGNYTE-ESO","aka":[],"tldr":"IGNYTE-ESO was the pivotal study for the second sarcoma TCR-T, with responses in 42% of patients with two rare sarcomas.","summary":"IGNYTE-ESO, trial NCT03967223 sponsored by Adaptimmune and GSK and reported in 2024, was the pivotal single-arm study for letetresgene autoleucel, the second engineered T-cell receptor therapy for sarcoma, with responses in 42 percent of patients with two rare sarcomas. In 64 patients with advanced NY-ESO-1-positive, HLA-A*02-positive synovial sarcoma or myxoid round cell liposarcoma the response rate by independent review was 42 percent in both histologies, with durable responses especially in synovial sarcoma and expected cytopenias and cytokine release syndrome, the basis for a biologics licence application due from US WorldMeds by the end of 2026. OnCo links it to sarcomas, TCR-T cell therapy and letetresgene autoleucel. Whether a small private company can bring a second TCR-T to market after Adaptimmune's retreat is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03967223","url":"https://clinicaltrials.gov/study/NCT03967223"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["tcr-t"],"targets":[],"drugs":["letetresgene-autoleucel"],"companies":["adaptimmune"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03967223","phase":"2","setting":"Advanced synovial sarcoma or myxoid/round cell liposarcoma, NY-ESO-1+, HLA-A*02+: lete-cel (single arm)","sponsor":"Adaptimmune / GSK","result":"ORR 42%.","started":"2019-12-31","startedType":"actual","yearReported":2024,"enrolled":64,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Lete-cel","n":64,"value":42}],"source":"https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2500"}]},"route":"/trials/ignyte-eso/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"tcr-t","kind":"technology","name":"TCR-T cell therapy","route":"/technologies/tcr-t/"}],"drug":[{"id":"letetresgene-autoleucel","kind":"drug","name":"Letetresgene autoleucel","route":"/drugs/letetresgene-autoleucel/"}],"company":[{"id":"adaptimmune","kind":"company","name":"Adaptimmune","route":"/companies/adaptimmune/"}]}}