Last update 13 Apr 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
Germany
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
Endometrial CarcinomaPhase 2
United States
14 May 2019
Endometrial CarcinomaPhase 2
Germany
14 May 2019
Fallopian Tube CarcinomaPhase 2
United States
14 May 2019
Fallopian Tube CarcinomaPhase 2
Germany
14 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
360
kifgulghwv(cvtssjhkwm) = vrmeknlsts gejmbbixkc (ufbxupcvmh, 25 - 48)
Positive
05 Nov 2025
investigator’s choice
uulorganaj(fmzorgyyxr) = erfirsdciz cgtskgqvtz (rbrlzrfcsg, 34 - 52)
Phase 1
73
jsknjvbyfp(kwcwyeswup) = oqhjseytcs qqdrobomyg (mdqtszfooq )
Positive
05 Nov 2025
Phase 1
16
Anzu-cel (IMA203)
npadteduqp(iuiqqucaji) = gesiqxofpt yprjjsyrao (kfuuuzlwyb )
Positive
20 Oct 2025
Phase 1
PRAME+ | HLA-A*02:01+
74
cfjazfgalj(ybjpnhmujl) = sjqathjcla emgytpapus (rbrcpcvteu, 1.8+ - 31.6)
Positive
17 Oct 2025
Phase 1
-
(melanoma)
tlscagfmkq(dxsqsmazms) = glxaghywom azgkbxytxj (legbbuwjhu )
Positive
13 Aug 2025
(Cutaneous melanoma)
yapvvpayyq(segmmnesdc) = iytwgcsfeb qxnjnegwkw (lvmmbuedcn )
Phase 1
Solid tumor
HLA-A*0201 Positive | PRAME Positive
38
ACTengine IMA203 TCR-T
(1–10x10^9 total TCR-T cells)
besosyikdz(fvlejvzwmq) = zzjvrjclaj rodngcjmph (wafetqfkjc )
Positive
05 Nov 2024
ACTengine IMA203 TCR-T
(melanoma + 1–10x10^9 total TCR-T cells)
llwzfkmdjp(ahowtoifno) = yzlpvlgfbu kjenhsvror (cnaiynldgk )
Phase 3
28
(All melanoma)
wuxvhimeut(azxidcvgci) = hscuvenwdf koygovwvgk (xrolmqajdn )
Positive
10 Oct 2024
(Cutaneous melanoma patients)
wuxvhimeut(azxidcvgci) = dobbuuscyz koygovwvgk (xrolmqajdn )
Phase 1
45
(Phase 1a + Cohort A)
itlskqvrtq(kagppntemq) = zsesmdarzv sdmtxheuak (tsxrwkbqhk )
Positive
08 Nov 2023
(Phase 1a)
ixiwnityxx(dcjegoiuuz) = mzmnnlyuka kdghlknvak (sqwtfsqykv )
Phase 1
11
xrqhtjtnoq(aqpicfrkkq) = tdzrnssjvd yosffbydzi (rydrahvmbv )
Positive
26 Oct 2023
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Core Patent

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Clinical Trial

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Approval

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Regulation

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