{"entity":{"id":"obecabtagene-autoleucel","kind":"drug","name":"Obecabtagene autoleucel","aka":[],"tldr":"A CD19 CAR-T built to grip and release quickly, which cut severe side effects and gave adults with relapsed ALL a real chance at durable remission.","summary":"FELIX (n=127 infused): ORR 77%, CR 55%, median EFS 11.9 months, with grade ≥3 CRS 2.4% and grade ≥3 ICANS 7%, far lower than first-generation CD19 CARs; longer follow-up shows ~40% event-free at 2 years, most without transplant. Approved 8 November 2024 (US) for adults with relapsed/refractory B-ALL, without a REMS. The low-affinity, fast-off-rate binder (CAT) reduces exhaustion and cytokine release.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Obecabtagene%20autoleucel"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":["autolus"],"institutions":[],"pathways":[],"terms":["crs","icans"],"trials":["felix"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Aucatzyl","code":"obe-cel, AUTO1","modality":"CAR-T (CD19, fast off-rate)","mechanism":"Autologous T cells with a CD19 CAR using the CAT scFv (fast target dissociation), 4-1BB costimulation; split-dose infusion by marrow blast burden.","approvals":[{"region":"US","year":2024,"indication":"Relapsed or refractory B-cell precursor ALL, adults"},{"region":"EU","year":2025,"indication":"Relapsed or refractory B-ALL, adults ≥26 years"}],"mechanismSteps":["Leukapheresis and lentiviral transduction with the CAT-CD19 CAR","Lymphodepletion with fludarabine/cyclophosphamide","Split dose on day 1 and day 10 sized to marrow blast percentage","Fast off-rate lets each CAR-T cell serially engage many blasts without over-activation","Persistence and B-cell aplasia continue for months in most responders"],"dosing":{"route":"IV, split infusion","schedule":"Total 410 × 10^6 CAR+ cells given on day 1 and day 10; day-1 fraction depends on marrow blasts (≤20% vs >20%)","monitoring":"CRS/ICANS (boxed warning) but no REMS; cytopenias; infections","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Aucatzyl"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":69,"grade3PlusPct":2.4,"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute"},{"event":"ICANS","anyGradePct":23,"grade3PlusPct":7},{"event":"Prolonged cytopenias","note":"Common; infection prophylaxis"}],"access":[],"regulatoryEvents":[{"date":"2024-11-08","type":"approval","region":"US","note":"FELIX; approved without REMS","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute"}]},"route":"/drugs/obecabtagene-autoleucel/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"all-paediatric-relapsed","kind":"cancer","name":"Relapsed and refractory acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-relapsed/"}],"technology":[{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"company":[{"id":"autolus","kind":"company","name":"Autolus Therapeutics","route":"/companies/autolus/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"}],"trial":[{"id":"felix","kind":"trial","name":"FELIX","route":"/trials/felix/"}],"paper":[{"id":"paper-eliana-tisagenlecleucel-nejm-2018","kind":"paper","name":"ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL","route":"/key-papers/paper-eliana-tisagenlecleucel-nejm-2018/"}]}}