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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.
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.
D-domain (non-scFv) BCMA binder CAR with 4-1BB costimulation; low immunogenicity, no framework-related aggregation. Connects to BCMA.
1.Anitocabtagene autoleucel slips into a pocket on BCMA.
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BLA accepted; PDUFA 27 December 2026 source
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Query for this drug: (TITLE:"Anitocabtagene autoleucel" OR ABSTRACT:"Anitocabtagene autoleucel" OR TITLE:"anito-cel" OR ABSTRACT:"anito-cel" OR TITLE:"CART-ddBCMA" OR ABSTRACT:"CART-ddBCMA") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Anitocabtagene autoleucel, not a curated reading list.
Shares iMMagine-1, Gilead Sciences (incl. Kite), BCMA, CAR-T cell therapy.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.
Shares BCMA, CAR-T cell therapy, Multiple myeloma.