# iMMagine-1

Source: https://onco.cc/trials/immagine-1/  
OnCo record `immagine-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

iMMagine-1 is the pivotal study behind anito-cel's BLA, with responses in nearly every patient.

## Summary

iMMagine-1, trial NCT05396885 sponsored by Arcellx and Kite and reported in 2025, is the pivotal single-arm study behind the biologics licence application for anitocabtagene autoleucel, a BCMA CAR-T, in relapsed or refractory myeloma after at least four prior lines. In 117 patients the response rate was 97 percent with complete response or better in about 62 percent at about twelve months, no delayed neurotoxicity or parkinsonism was reported and cytokine release syndrome was mostly low grade; the application was accepted in February 2026 with a PDUFA date in December 2026. OnCo links it to multiple myeloma and anito-cel. Whether the absence of delayed neurotoxicity holds up with longer follow-up and larger numbers is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05396885
- Phase: 2
- Setting: Relapsed/refractory myeloma after ≥4 lines: anito-cel single infusion
- Sponsor: Arcellx / Kite
- Enrolled: 117
- Result: ORR 97%.
- Outcomes: Objective response rate: Anito-cel 97%

## Sources

- ClinicalTrials.gov NCT05396885: https://clinicaltrials.gov/study/NCT05396885

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Relapsed or refractory multiple myeloma](https://onco.cc/cancers/myeloma-relapsed-refractory/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- drugs: [Anitocabtagene autoleucel](https://onco.cc/drugs/anitocabtagene-autoleucel/)
- companies: [Arcellx](https://onco.cc/companies/arcellx/)

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JSON: https://onco.cc/api/v1/entities/immagine-1.json