# Anitocabtagene autoleucel

Source: https://onco.cc/drugs/anitocabtagene-autoleucel/  
OnCo record `anitocabtagene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- 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.

## Sources

- ClinicalTrials.gov NCT05396885 (iMMagine-1): https://clinicaltrials.gov/study/NCT05396885

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [BCMA](https://onco.cc/targets/bcma/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- trials: [A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma](https://onco.cc/trials/nct06413498/), [iMMagine-1](https://onco.cc/trials/immagine-1/)

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