OnCo
drugsProductPhase 3

Anitocabtagene autoleucel

Anitocabtagene autoleucel is a BCMA CAR-T with a novel small synthetic binder that produced responses in 97% of heavily pretreated patients; an FDA decision is due in December 2026.

iMMagine-1 (phase 2, ≥4 prior lines): ORR 97%, high MRD negativity, no delayed parkinsonism reported to date. BLA accepted February 2026; PDUFA 27 December 2026. Gilead/Kite acquired Arcellx (closed April 2026). iMMagine-3 (phase 3, second line and beyond) and iMMagine-4 (newly diagnosed) follow.

Schematic of the modality · CAR-T (BCMA, D-domain binder) · not a molecule; see the CAR-T cell therapy page
How it works, step by step · animated schematic, not to scale
CAR-T cell therapy
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.
Brand / code
anito-cel, CART-ddBCMA

Regulatory

1top
  1. Feb 2026Filing / dealUS

    BLA accepted; PDUFA 27 December 2026 source

Trials

top

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Anitocabtagene autoleucel
intervention: Anitocabtagene autoleucel
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Latest papers

top
Literature trend1 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

5top