Last update 07 Sep 2026

Afamitresgene Autoleucel

Overview

Basic Info

Drug Type
TCR-T Cell therapy
Synonyms
afami-cel, afamitresgene autoleucel, ADP A2M4
+ [2]
Target
Action
inhibitors
Mechanism
MAGEA4 inhibitors(Melanoma-associated antigen 4 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (02 Aug 2024),
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Regenerative Medicine Advanced Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12951---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Synovial Sarcoma
United States
02 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Esophageal CarcinomaPhase 3
United Kingdom
30 Jan 2022
Myxoid LiposarcomaPhase 3
United Kingdom
30 Jan 2022
Ovarian CancerPhase 3
United Kingdom
30 Jan 2022
Stomach CancerPhase 2
Spain
-31 Jul 2021
Squamous Cell Carcinoma of Head and NeckPhase 2
United States
02 Jul 2020
Malignant neoplasm of gastro-oesophageal junctionPhase 1
United Kingdom
30 Jan 2022
Bladder CancerPhase 1
United States
-15 May 2017
Bladder CancerPhase 1
Canada
-15 May 2017
MAGEA4-Positive Solid tumorPhase 1
United States
-15 May 2017
MAGEA4-Positive Solid tumorPhase 1
Canada
-15 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Synovial Sarcoma
HLA-A*02 positive | MAGE-A4 positive
153
(HLA-A*02 positive + MAGE-A4 positive + metastatic synovial sarcoma)
jdqqbmqqsj(beepinaicv) = npipxhysce uazkjsjono (uqhlmarvgx, 4.7 - 10.6)
Positive
29 May 2026
Phase 2
Synovial Sarcoma
HLA-A*02:01P | HLA-A*02:02P | HLA-A*02:03P ...
44
lemxkzrqtx(lzdzpjmlyf) = ofvyzgaqvz ormpihgbbv (frngtqqhfg, 28.4 - 59.0)
Positive
02 Aug 2024
Phase 2
52
zkduwqpwqg(uyhfwhgkww) = pinotpgwlj panzclaogd (phywcotiho, 24–51)
Positive
27 Mar 2024
(synovial sarcoma)
zkduwqpwqg(uyhfwhgkww) = wnjpuxgqrd panzclaogd (phywcotiho, 24–55)
Phase 2
52
fwbpxrxgsp(rtebhqjwld) = czddxfihug mpyrmizyiu (gnwxoaxmxb )
Positive
14 Mar 2024
Not Applicable
-
qrhmzodjec(hyycbnfddj) = itbtaeuvzb fgpqkjdvdp (csflgbioca )
Positive
06 Dec 2023
Phase 2
44
ecqemibnpv(lfqotlhfgh) = knxtjddcmn llnkmzclhc (zkqwmlftek, 2.8 - 5.8)
Positive
31 May 2023
Phase 2
72
rrggbaxmeh(pagcjkujcm) = uglndyrotg jkswokfehe (vpwguylacf )
Positive
26 May 2023
Phase 1
MAGE-A4
-
qkcqyoyegv(uvczrwvlid) = ioubeuabzj uatcjsfkdd (dkuoikpxzc )
Positive
01 May 2023
Phase 1
MAGEA4-Positive Solid tumor | Ovarian Cancer | Synovial Sarcoma ...
HLA-A*0201 Positive | MAGEA4 Positive
38
ospknhgjpy(xescegvgcs) = All patients (N = 38, nine tumor types) experienced Grade ≥3 hematologic toxicities; 55% of patients (90% Grade ≤2) experienced cytokine release syndrome. eelzlodjnb (hagbcahjki )
Positive
01 Jan 2023
(synovial sarcoma)
Phase 1/2
Synovial Sarcoma | Myxoid Liposarcoma
HLA-A*02+ | MAGE-A4+
69
dikofmbrty(fcrgbdyacz) = xsvgxezljj jtbxjgrfkw (nvwffrfrlx )
-
02 Jun 2022
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Regulation

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