{"entity":{"id":"cartitude-1","kind":"trial","name":"CARTITUDE-1","aka":[],"tldr":"The study that showed one CAR-T infusion could keep a third of heavily pretreated myeloma patients progression-free for five years without further treatment.","summary":"CARTITUDE-1, trial NCT03548207 sponsored by Janssen and Legend and reported in 2021, was the study that showed one CAR-T infusion of ciltacabtagene autoleucel could keep a third of heavily pretreated, triple-class-exposed myeloma patients progression-free for five years without further treatment. In 97 patients after at least three prior lines the response rate was 98 percent with stringent complete responses in 83 percent, and the five-year JCO update in 2025 found a third still progression-free with no maintenance and sustained MRD negativity in most, while movement disorders occurred in about five percent of the early cohort. OnCo links it to multiple myeloma, CAR-T, cilta-cel, Fangliang Zhang, Jesús G. Berdeja, the LEGEND-2 trial and the CARTITUDE-1 paper. Whether those long-term remissions represent cures is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03548207","url":"https://clinicaltrials.gov/study/NCT03548207"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["ciltacabtagene-autoleucel"],"companies":["johnson-johnson","legend-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhang-fangliang","jesus-berdeja"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03548207","phase":"1/2","setting":"Relapsed/refractory myeloma after ≥3 lines, triple-class exposed: cilta-cel single infusion","sponsor":"Janssen / Legend","result":"ORR 98%; ~33% progression-free at 5 years without maintenance.","started":"2018-06-29","startedType":"actual","yearReported":2021,"enrolled":97,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Cilta-cel","n":97,"value":97.9}],"source":"https://doi.org/10.1016/S0140-6736(21)00933-8"},{"endpoint":"Progression-free at 5 years","unit":"%","arms":[{"name":"Cilta-cel","value":33}],"source":"https://ascopubs.org/doi/10.1200/JCO-25-00760"}]},"route":"/trials/cartitude-1/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","route":"/drugs/ciltacabtagene-autoleucel/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"},{"id":"legend-biotech","kind":"company","name":"Legend Biotech","route":"/companies/legend-biotech/"}],"person":[{"id":"zhang-fangliang","kind":"person","name":"Fangliang (Frank) Zhang","route":"/people/zhang-fangliang/"},{"id":"jesus-berdeja","kind":"person","name":"Jesús G. Berdeja","route":"/people/jesus-berdeja/"}],"paper":[{"id":"paper-cartitude-1-cilta-cel-lancet-2021","kind":"paper","name":"CARTITUDE-1: cilta-cel, a BCMA CAR-T, in heavily pretreated myeloma","route":"/key-papers/paper-cartitude-1-cilta-cel-lancet-2021/"},{"id":"paper-ciltacabtagene-autoleucel-multiple-myeloma-clin-cancer-res-2024","kind":"paper","name":"FDA Approval Summary: Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma","route":"/key-papers/paper-ciltacabtagene-autoleucel-multiple-myeloma-clin-cancer-res-2024/"}],"trial":[{"id":"legend-2","kind":"trial","name":"LEGEND-2","route":"/trials/legend-2/"}]}}