iMMagine-1
iMMagine-1 is the pivotal study behind anito-cel's BLA, with responses in nearly every patient.
ORR 97%, ≥CR ~62% at ~12 months; no delayed neurotoxicity or parkinsonism reported; low-grade CRS in most. BLA accepted February 2026, PDUFA December 2026.
Setting
Relapsed/refractory myeloma after ≥4 lines: anito-cel single infusion
Phase
Phase 2
Sponsor
Arcellx / Kite
Registry
Headline result
ORR 97%.
Reported
2025
Enrolled
117
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 97 out of 100 people had their tumour shrink with Anito-cel.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Relapsed/refractory myeloma after ≥4 lines: anito-cel single infusion. People in a different situation may not see the same effect.
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 participants enrolled.
Objective response rateprimary
Anito-cel97 of 100
n = 117
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Anito-cel | 117 | 97% | — | — | — |