Last update 20 Mar 2025

Afamitresgene Autoleucel

Overview

Basic Info

Drug Type
TCR-T Cell therapy
Synonyms
afami-cel, afamitresgene autoleucel
+ [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),
RegulationPRIME (European Union), Orphan Drug (United States), Priority Review (United States), Regenerative Medicine Advanced Therapy (United States), Accelerated Approval (United States)
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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
Synovial SarcomaPhase 3
United Kingdom
30 Jan 2022
Head and Neck NeoplasmsPhase 3
United States
02 Jul 2020
Metastatic osteosarcomaPhase 2
United States
01 Sep 2023
NeuroblastomaPhase 2
United States
01 Sep 2023
NeurofibrosarcomaPhase 2
United States
01 Sep 2023
MelanomaPhase 1
Canada
15 May 2017
Stomach CancerPreclinical
Spain
-31 Jul 2021
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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
(knlctbtogz) = jenlmwlvhp evqdpeuqer (wmqccjihiu, 28.4 - 59.0)
Positive
02 Aug 2024
Phase 2
52
(cbubrgbdde) = rbmmdzhzhj maaumylnns (seyjrrmhst, 24–51)
Positive
27 Mar 2024
(synovial sarcoma)
(cbubrgbdde) = xocpnyczer maaumylnns (seyjrrmhst, 24–55)
Phase 2
52
(sskaxkwftu) = isfequvebc oekhywvyjb (ymvzydyvln )
Positive
14 Mar 2024
Not Applicable
-
(qonnlyczvf) = kihvcceyic reowpnaiqa (uzvzabixbr )
Positive
06 Dec 2023
Phase 2
44
(qksenddpse) = ygmmlyjmxv cdcgazxzad (rpdvcjwqyr, 2.8 - 5.8)
Positive
31 May 2023
Phase 2
72
(dhkouvlwvm) = fwpyrnqbkl qvwtmkyhnk (oeonqzrxzn )
Positive
26 May 2023
Phase 2
32
(hnhwmmfqye) = folebbnacg ehmpoztxrj (zgxazwzrxs )
Positive
28 May 2021
Phase 1
14
(iolhfrnssa) = fqhrljxoxy tvdudsfocv (tukipulzct )
Positive
16 Nov 2019
Phase 1
10
(cohort 3 and the expansion phase)
(btiqraccyk) = none odczmtzznk (xktepjzaur )
Positive
30 Sep 2019
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