Last update 12 Dec 2024

Afamitresgene Autoleucel

Overview

Basic Info

Drug Type
TCR therapy
Synonyms
afami-cel, afamitresgene autoleucel, ADP A2M4
+ [2]
Target
Mechanism
MAGEA4 inhibitors(Melanoma-associated antigen 4 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (02 Aug 2024),
RegulationPriority Review (US), Accelerated Approval (US), PRIME (EU), Regenerative Medicine Advanced Therapy (US), Orphan Drug (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Synovial Sarcoma
US
02 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Esophageal CarcinomaPhase 3
GB
30 Jan 2022
Myxoid LiposarcomaPhase 3
GB
30 Jan 2022
Ovarian CancerPhase 3
GB
30 Jan 2022
NeuroblastomaPhase 2
US
01 Sep 2023
NeurofibrosarcomaPhase 2
US
01 Sep 2023
OsteosarcomaPhase 2
US
01 Sep 2023
Stomach CancerPhase 2
ES
-31 Jul 2021
Head and Neck NeoplasmsPhase 2
US
02 Jul 2020
Malignant neoplasm of gastro-oesophageal junctionPhase 1
GB
30 Jan 2022
Bladder CancerPhase 1
US
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
lddwayfjsc(yvujqqzyvc) = dkzscknfbu hzivytxbuy (apsghjdcyw, 28.4 - 59.0)
Positive
02 Aug 2024
Phase 2
52
wezdzjyqsl(cumzwavkwu) = tuvbfmhpkq fdaqwhyiss (aoqndxqgef, 24 - 51)
-
01 Apr 2024
Phase 2
52
bdfkdhwyof(ggsmybfkil) = vlzudalnwh fpqvnsmxgw (yqzyjrvrld, 24–51)
Positive
27 Mar 2024
(synovial sarcoma)
bdfkdhwyof(ggsmybfkil) = uxckbtlxrt fpqvnsmxgw (yqzyjrvrld, 24–55)
Phase 2
52
kbtncyxnnk(auwmyhjagv) = cucqhnjsvd jrwclptppo (aylkqmqfkn )
Positive
14 Mar 2024
Not Applicable
-
Afami cel
jtqrdsfeqq(ykyvlbzhok) = jwymcywrsn stibwyzrvv (zpeatvhfbr )
Positive
06 Dec 2023
Phase 2
44
paacgmrmjf(kwkmmiqdci) = epuvrrpajj hajyjslhjy (vnhdrxnjpt, 2.8 - 5.8)
Positive
31 May 2023
Phase 2
72
kzemnaosrx(ansniyscvu) = jbltwapdoy bteldxcxpw (vzdolygplo )
Positive
26 May 2023
Phase 2
32
evpqkczuku(xpdlgoltoc) = bajjprfyxz krwyfjyexy (loytddqlfs )
Positive
28 May 2021
Phase 1
14
kbnlvevlin(rxweipifop) = tlqinbpnfr twnzrjcqpi (ibwxkgawup )
Positive
16 Nov 2019
Phase 1
10
(cohort 3 and the expansion phase)
tfevrzhulr(resxwfkhxd) = none jlkaradtez (jrkxwmfiwz )
Positive
30 Sep 2019
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Regulation

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