{"entity":{"id":"anitocabtagene-autoleucel","kind":"drug","name":"Anitocabtagene autoleucel","aka":[],"tldr":"Anitocabtagene autoleucel is a BCMA CAR-T whose binder is a small synthetic D-domain protein rather than an antibody fragment, a design chosen for low immunogenicity. In heavily pretreated myeloma it produced responses in 97% of patients with mostly low-grade cytokine release syndrome and no delayed parkinsonism reported, and an FDA decision is due on 27 December 2026.","summary":"Anitocabtagene autoleucel is a BCMA CAR-T that uses a small synthetic D-domain binder instead of an antibody-derived scFv, with 4-1BB costimulation; the design gives low immunogenicity and avoids framework-related aggregation. In the pivotal phase 2 iMMagine-1 study of patients with at least 4 prior lines, it produced ORR 97% and high MRD negativity, with mostly low-grade cytokine release syndrome and no delayed parkinsonism reported to date. The BLA was accepted in February 2026 with a PDUFA date of 27 December 2026. Gilead's Kite acquired developer Arcellx in a deal that closed in April 2026. The phase 3 iMMagine-3 (second line and beyond) and iMMagine-4 (newly diagnosed) trials will show whether the safety profile holds in earlier populations. It is a next-generation myeloma CAR-T promising comparable efficacy with fewer rare neurological complications.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05396885 (iMMagine-1)","url":"https://clinicaltrials.gov/study/NCT05396885"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":[],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":["immagine-1","nct06413498"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"anito-cel, CART-ddBCMA","modality":"CAR-T (BCMA, D-domain binder)","mechanism":"D-domain (non-scFv) BCMA binder CAR with 4-1BB costimulation; low immunogenicity, no framework-related aggregation.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-02","type":"filing","region":"US","note":"BLA accepted; PDUFA 27 December 2026","source":"https://allsci.com/news/earnings-call-insights/gileads-q126-earnings-call-anito-cel-poised-for-december-pdufa-decision-three-acquisitions-near-inflection-points/"}]},"route":"/drugs/anitocabtagene-autoleucel/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"technology":[{"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":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"trial":[{"id":"nct06413498","kind":"trial","name":"A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma","route":"/trials/nct06413498/"},{"id":"immagine-1","kind":"trial","name":"iMMagine-1","route":"/trials/immagine-1/"}]}}