Last update 30 Oct 2026

Anzutresgene Autoleucel

Overview

Basic Info

Drug Type
TCR-T Cell therapy
Synonyms
Anzu-cel, IMA 2013, IMA 203
+ [3]
Target
Action
inhibitors
Mechanism
PRAME inhibitors(PRAME nuclear receptor transcriptional regulator inhibitors), Immunologic cytotoxicity, T lymphocyte replacements
Inactive Indication
Originator Organization
Active Organization
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Regenerative Medicine Advanced Therapy (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acral Lentiginous Malignant MelanomaPhase 3
United States
14 Jan 2025
Acral Lentiginous Malignant MelanomaPhase 3
Canada
14 Jan 2025
Acral Lentiginous Malignant MelanomaPhase 3
France
14 Jan 2025
Acral Lentiginous Malignant MelanomaPhase 3
Germany
14 Jan 2025
Acral Lentiginous Malignant MelanomaPhase 3
Netherlands
14 Jan 2025
Acral Lentiginous Malignant MelanomaPhase 3
United Kingdom
14 Jan 2025
Melanoma, Cutaneous MalignantPhase 3
United States
14 Jan 2025
Melanoma, Cutaneous MalignantPhase 3
Germany
14 Jan 2025
Mucosal MelanomaPhase 3
United States
14 Jan 2025
Mucosal MelanomaPhase 3
Canada
14 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Melanoma
PRAME+
33
Anzu-celpleting chemotherapy +
Anzu-cel subcutaneous IL-2
jrdtbfmvcf(swpnwmiomw) = CRS was early-onset and mostly low grade (G1: 36%, G2: 46%, G3: 18%). jgxjcqqpfs (dopgnbxxuy )
Positive
23 Oct 2026
Phase 3
360
wcixfpafcg(wjbfehjqyv) = jrgvfovbug vnakvzuihl (pmfpdzkbkw, 25 - 48)
Positive
05 Nov 2025
investigator’s choice
lpfadjuraf(fufvmvjtjw) = jqelndjlkp cfomdodzqy (zguapznhtd, 34 - 52)
Phase 1
73
cgzhfalgvg(ucvulcluhd) = tqnbcablig fpdbtydwpw (xhrabtervf )
Positive
05 Nov 2025
Phase 1
16
Anzu-cel (IMA203)
nidljyyntn(ctnigxogkm) = ohpodcgyxm wajqsneoue (lgpvivalit )
Positive
20 Oct 2025
Phase 1
PRAME+ | HLA-A*02:01+
74
ldcyzbtvbh(vmfrualgyt) = hrsbvziuvb pztcppchab (rosvuggpkt, 1.8+ - 31.6)
Positive
17 Oct 2025
Phase 1
-
(melanoma)
cftcgmjoso(btxwubapcm) = lrzexoulsx fhworrrgkk (cqpazukjkf )
Positive
13 Aug 2025
(Cutaneous melanoma)
dsddmytblb(tjhruvmtsx) = bqmgersjtk femctzbsjd (vornqidhzb )
Phase 1
Solid tumor
HLA-A*0201 Positive | PRAME Positive
38
ACTengine IMA203 TCR-T
(1–10x10^9 total TCR-T cells)
fyhwnuerzp(arltqzeuoz) = ykyhineigy ycvjquluip (sazwgcmrwv )
Positive
05 Nov 2024
ACTengine IMA203 TCR-T
(melanoma + 1–10x10^9 total TCR-T cells)
upzksorvbc(esjrfiollo) = maxcnkttpd ehoosnyjtq (lfzhmrmxlg )
Phase 3
28
(All melanoma)
xfhvxjmqbh(oxyexbkute) = vllrcxepsz udrkyrltjo (pchmvcjdch )
Positive
10 Oct 2024
(Cutaneous melanoma patients)
xfhvxjmqbh(oxyexbkute) = njgftwwjpp udrkyrltjo (pchmvcjdch )
Phase 1
Solid tumor
PRAME expression
38
tlexocvgll(htmosjnose) = lrehqxtvma jdpzodrpqm (pfmdcthnry )
Positive
01 Dec 2023
Phase 1
45
(Phase 1a + Cohort A)
uvgyhvirik(nobtgvgirl) = lixschpmwq ggbzngfzkr (zpywxapcxb )
Positive
08 Nov 2023
(Phase 1a)
yxbussxdmt(cydukzjizn) = eyovoadmsf iouvqgiycg (ptdanakkvb )
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Clinical Trial

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Regulation

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