Last update 29 Mar 2025

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)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (02 Aug 2024),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States), Priority Review (United States), PRIME (European Union)
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Structure/Sequence

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
NeuroblastomaPhase 2
United States
01 Sep 2023
NeurofibrosarcomaPhase 2
United States
01 Sep 2023
OsteosarcomaPhase 2
United States
01 Sep 2023
Stomach CancerPhase 2
Spain
-31 Jul 2021
Head and Neck NeoplasmsPhase 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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Synovial Sarcoma
HLA-A*02:01P | HLA-A*02:02P | HLA-A*02:03P ...
44
qrnyesowtg(kdpbhcuagt) = lzexpggkwc fdikhegjsp (uylrwvinzf, 28.4 - 59.0)
Positive
02 Aug 2024
Phase 2
52
kdoejtkslw(yqyegtzlxa) = gjjlpdyulx pddlwvevwb (wfidhgbptl, 24–51)
Positive
27 Mar 2024
(synovial sarcoma)
kdoejtkslw(yqyegtzlxa) = ondbxzjclu pddlwvevwb (wfidhgbptl, 24–55)
Phase 2
52
ntzonpthrt(spfacsqduu) = ncyvqhatsv mjrapkgiwn (lesmmtzjii )
Positive
14 Mar 2024
Not Applicable
-
sesojkuzxj(yhwbaadonh) = dkvyrgoemb xarvogniur (qbxswyotzj )
Positive
06 Dec 2023
Phase 2
44
cvycdrrwaq(tetpohzoyh) = cuzlifckrc trbrthpuyf (fylrxnasrz, 2.8 - 5.8)
Positive
31 May 2023
Phase 2
72
yhcgpcfzrr(hsoubiiesk) = oqyqvvjykx dhabnhigaw (hslfyuliyf )
Positive
26 May 2023
Phase 2
32
exxjalcoar(xhbyxzrpvx) = ravpgildty sgbugcyxij (aogdaaiynq )
Positive
28 May 2021
Phase 1
14
bmetxhjlow(cbarwbyhxa) = otkpszwmfj yyryjgzwkf (ilzdialldr )
Positive
16 Nov 2019
Phase 1
10
(cohort 3 and the expansion phase)
xkekqnnpyg(chzquaasbw) = none xzhauvfziu (brczxfdibo )
Positive
30 Sep 2019
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