{"entity":{"id":"ciltacabtagene-autoleucel","kind":"drug","name":"Ciltacabtagene autoleucel","aka":[],"tldr":"Ciltacabtagene autoleucel is a one-time BCMA CAR-T for myeloma that, in CARTITUDE-4, cut the risk of death by about 45% compared with standard regimens.","summary":"Approved 2022 (≥4 lines) and 2024 (≥1 prior line, lenalidomide-refractory; CARTITUDE-4 with OS benefit HR 0.55). A third of patients in CARTITUDE-1 remain progression-free at 5 years without maintenance. Delayed neurotoxicity (parkinsonism) and secondary malignancies are rare but notable. Legend Biotech/Johnson & Johnson.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Ciltacabtagene_autoleucel","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ciltacabtagene%20autoleucel"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":[],"companies":["legend-biotech","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06550895","nct04133636","nct06577025","nct07149857"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Carvykti","code":"cilta-cel","modality":"CAR-T (BCMA)","mechanism":"Two BCMA-binding VHH domains, 4-1BB costimulation; lentiviral.","approvals":[{"region":"US","year":2022,"indication":"Relapsed/refractory myeloma ≥4 lines"},{"region":"US","year":2024,"indication":"Relapsed myeloma after ≥1 line, lenalidomide-refractory"}],"mechanismSteps":["Patient's T cells are collected by leukapheresis","Cells are engineered to express a CAR against BCMA (two VHH binders) and expanded","Patient receives lymphodepleting chemotherapy","CAR-T cells are infused, home to tumour, and expand","CAR binds BCMA (two VHH binders); T cell kills the tumour cell and proliferates","Memory CAR-T cells persist and patrol"],"dosing":{"route":"Single IV infusion after lymphodepletion","schedule":"0.5 to 1.0 × 10⁶ CAR+ viable T cells/kg (max 1 × 10⁸); cyclophosphamide 300 mg/m² + fludarabine 30 mg/m² days −5 to −3","modifications":"Delay infusion for active infection; tocilizumab and steroids for CRS; anakinra for refractory","monitoring":"Daily monitoring for 10 days for CRS/ICANS; delayed neurotoxicity (parkinsonism) for months; blood counts and IgG; secondary malignancy surveillance for 15 years","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":78,"grade3PlusPct":3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"Neutropenia (grade 3+)","grade3PlusPct":95,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"Hypogammaglobulinaemia","anyGradePct":94,"grade3PlusPct":9,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"Infections (grade 3+)","grade3PlusPct":24,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"ICANS","anyGradePct":7,"grade3PlusPct":0.5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"Parkinsonism / movement disorders","anyGradePct":1,"grade3PlusPct":0,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"},{"event":"Secondary haematological malignancies","anyGradePct":3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2","note":"CARTITUDE-4, n=188"}],"access":[{"country":"US","listPrice":"$465,000 per infusion (list price at launch, 2022; 2026 list higher)","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.janssencarepath.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for relapsed myeloma after ≥1 line, lenalidomide-refractory (2025)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2019-12","type":"designation","region":"US","note":"Breakthrough Therapy designation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-02-28","type":"approval","region":"US","note":"Relapsed/refractory myeloma after ≥4 lines (CARTITUDE-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-04-05","type":"approval","region":"US","note":"Relapsed myeloma after ≥1 prior line, lenalidomide-refractory (CARTITUDE-4)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-01-19","type":"label-change","region":"US","note":"Class boxed warning for T-cell malignancies","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-06","type":"label-change","region":"US","note":"REMS requirements removed for CAR-T class","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/ciltacabtagene-autoleucel/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-transplant-eligible","kind":"cancer","name":"Newly diagnosed multiple myeloma, transplant-eligible","route":"/cancers/myeloma-transplant-eligible/"},{"id":"plasma-cell-leukaemia","kind":"cancer","name":"Plasma cell leukaemia","route":"/cancers/plasma-cell-leukaemia/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"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":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"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/"}],"trial":[{"id":"nct06550895","kind":"trial","name":"A Study of Ciltacabtagene 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Autoleucel","route":"/trials/nct07149857/"},{"id":"cartitude-1","kind":"trial","name":"CARTITUDE-1","route":"/trials/cartitude-1/"},{"id":"cartitude-4","kind":"trial","name":"CARTITUDE-4","route":"/trials/cartitude-4/"},{"id":"cartitude-5","kind":"trial","name":"CARTITUDE-5","route":"/trials/cartitude-5/"},{"id":"cartitude-6","kind":"trial","name":"CARTITUDE-6","route":"/trials/cartitude-6/"},{"id":"legend-2","kind":"trial","name":"LEGEND-2","route":"/trials/legend-2/"}],"idea":[{"id":"idea-reg-cart-outcomes-refund","kind":"idea","name":"Full refund for CAR-T if the patient has not responded at three months","route":"/ideas/idea-reg-cart-outcomes-refund/"},{"id":"idea-reg-vein-to-vein-public-benchmark","kind":"idea","name":"Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product","route":"/ideas/idea-reg-vein-to-vein-public-benchmark/"},{"id":"idea-car-t-replaces-transplant","kind":"idea","name":"One CAR-T infusion instead of autologous transplant","route":"/ideas/idea-car-t-replaces-transplant/"},{"id":"idea-fund-pay-for-cure-annuities","kind":"idea","name":"Outcome-based annuity payments for potentially curative one-time therapies","route":"/ideas/idea-fund-pay-for-cure-annuities/"},{"id":"idea-moon-pay-for-cure-contracts","kind":"idea","name":"Pay-for-cure contracts: instalment payments for curative therapies contingent on durable remission","route":"/ideas/idea-moon-pay-for-cure-contracts/"}],"roadmap":[{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"}],"person":[{"id":"zhang-fangliang","kind":"person","name":"Fangliang (Frank) Zhang","route":"/people/zhang-fangliang/"},{"id":"jesus-berdeja","kind":"person","name":"Jesús G. 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