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iMMagine-1 is the pivotal study behind anito-cel's BLA, with responses in nearly every patient.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
117 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Anito-cel | 117 | 97% | - | - | - |
Shares Anitocabtagene autoleucel, Relapsed or refractory multiple myeloma, CAR-T cell therapy, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, CAR-T cell therapy, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares Relapsed or refractory multiple myeloma, Multiple myeloma.