{"entity":{"id":"felix","kind":"trial","name":"FELIX","aka":[],"tldr":"The trial that showed a gentler CAR-T design could treat adult ALL with a fraction of the severe side effects.","summary":"FELIX, trial NCT04404660 sponsored by Autolus and published in the New England Journal of Medicine in 2024, showed that a gentler CAR-T design, obecabtagene autoleucel, could treat adult relapsed or refractory B-cell acute lymphoblastic leukaemia with a fraction of the severe side effects of earlier products. Of 153 enrolled, 127 were infused; the overall remission rate was 77 percent with complete remission in 55 percent, severe cytokine release syndrome occurred in under three percent, and about forty percent were event-free at two years, most without transplant, leading to FDA approval on 8 November 2024 without a REMS programme. OnCo links it to acute lymphoblastic leukaemia, CAR-T, CD19 as a target and obecabtagene autoleucel, and the UCL predecessor ALLCAR19 showed the same profile. Whether the fast-off-rate design generalises to other CAR-T targets is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04404660","url":"https://clinicaltrials.gov/study/NCT04404660"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":["obecabtagene-autoleucel"],"companies":["autolus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04404660","phase":"1/2","setting":"Relapsed or refractory B-ALL, adults: obecabtagene autoleucel single split-dose course","sponsor":"Autolus","result":"ORR 77%, CR 55%; grade ≥3 CRS 2.4%.","started":"2020-06-03","startedType":"actual","yearReported":2024,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall remission (CR + CRi)","primary":true,"unit":"%","arms":[{"name":"Obe-cel","n":127,"value":77}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2406526"},{"endpoint":"Complete remission","unit":"%","arms":[{"name":"Obe-cel","value":55}],"source":"https://doi.org/10.1001/jama.2024.28312"},{"endpoint":"Event-free survival (median)","unit":"months","arms":[{"name":"Obe-cel","value":11.9}],"source":"https://doi.org/10.1001/jama.2024.28312"}],"replication":"ALLCAR19 (the UCL phase 1 predecessor) showed the same low-toxicity, high-remission profile."},"route":"/trials/felix/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-relapsed","kind":"cancer","name":"Relapsed and refractory acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-relapsed/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"drug":[{"id":"obecabtagene-autoleucel","kind":"drug","name":"Obecabtagene autoleucel","route":"/drugs/obecabtagene-autoleucel/"}],"company":[{"id":"autolus","kind":"company","name":"Autolus Therapeutics","route":"/companies/autolus/"}]}}