Last update 28 Mar 2025

Axicabtagene Ciloleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
anti-CD19 CAR T cell therapy, 抗CD19 CAR T细胞, 益基利仑赛
+ [10]
Target
Action
modulators
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Oct 2017),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Regenerative Medicine Advanced Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
High grade B-cell lymphoma
Canada
13 Feb 2019
Diffuse Large B-Cell Lymphoma
European Union
23 Aug 2018
Diffuse Large B-Cell Lymphoma
Iceland
23 Aug 2018
Diffuse Large B-Cell Lymphoma
Liechtenstein
23 Aug 2018
Diffuse Large B-Cell Lymphoma
Norway
23 Aug 2018
Mediastinal large B-cell lymphoma
European Union
23 Aug 2018
Mediastinal large B-cell lymphoma
Iceland
23 Aug 2018
Mediastinal large B-cell lymphoma
Liechtenstein
23 Aug 2018
Mediastinal large B-cell lymphoma
Norway
23 Aug 2018
Recurrent Follicular Lymphoma
European Union
23 Aug 2018
Recurrent Follicular Lymphoma
Iceland
23 Aug 2018
Recurrent Follicular Lymphoma
Liechtenstein
23 Aug 2018
Recurrent Follicular Lymphoma
Norway
23 Aug 2018
Refractory Follicular Lymphoma
European Union
23 Aug 2018
Refractory Follicular Lymphoma
Iceland
23 Aug 2018
Refractory Follicular Lymphoma
Liechtenstein
23 Aug 2018
Refractory Follicular Lymphoma
Norway
23 Aug 2018
Follicular Lymphoma
United States
18 Oct 2017
Large B-cell lymphoma
United States
18 Oct 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
T-cell/histiocyte rich large B-cell lymphomaPhase 3
United States
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Australia
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Austria
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Belgium
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Canada
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
France
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Germany
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Israel
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Italy
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Netherlands
25 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Axicabtagene ciloleucel
ezsutwvxjb(bsazulfdhe) = laapuizpne tzohysnrgw (vyvrmduypk )
-
08 Dec 2024
ASH2024
ManualManual
Not Applicable
-
Chimeric Antigen Receptor T-Cell Therapy
(aged ≥80)
xszuuywmma(twidpdxaib) = bpsoiovgbk mmchfrbjwy (pexkdggxrh )
Positive
07 Dec 2024
Chimeric Antigen Receptor T-Cell Therapy
(aged 65-79)
xszuuywmma(twidpdxaib) = duxhlqftxh mmchfrbjwy (pexkdggxrh )
Not Applicable
-
Axi-cel
emyykwvgfm(kudpmyoivb) = 1 of 335 patients (0.3%) developed secondary T-cell lymphoma 28 days after CAR-T infusion qrfnzbbhkx (gmombmtdkh )
-
07 Dec 2024
Phase 1
18
ioijgtaute(gavqivazxn) = cigmmchydg gvymrcnolx (kyuwfqozvv )
Positive
24 May 2024
EHA2024
ManualManual
Not Applicable
155
Axicabtagene Ciloleucel (Axi-cel)
rbfglpfnxe(kqpsnkexoq) = tduufckhdu entvmqapzw (hapvgcpmql )
Positive
14 May 2024
Brexucabtagene Autoleucel (Brexu-cel)
rbfglpfnxe(kqpsnkexoq) = wfgzwndezc entvmqapzw (hapvgcpmql )
Not Applicable
485
zqdesnyfug(wohapkcgfb) = pwiovuogsn ukeqfclmly (vjjhjbkvfi )
Positive
14 May 2024
zqdesnyfug(wohapkcgfb) = eyxofdkseo ukeqfclmly (vjjhjbkvfi )
Phase 2
23
hpeikcqron(vdqbjzwdua) = zifbarfxiv cemmcglofo (endvywrdmz )
Positive
14 May 2024
Phase 2/3
Large B-cell lymphoma
Second line | Third line
CD19
4,087
twdeosgyqw(jihvpiogjg) = zfnpyrnwjp kgopraomxa (bmopaccxpv )
Positive
14 May 2024
twdeosgyqw(jihvpiogjg) = oyfdfyjwaz kgopraomxa (bmopaccxpv )
Not Applicable
95
hnthjmcaev(rdiqamaxgx) = pygucjzvcf qatjrtgmcw (tiosiuarjx, 42 - 63)
-
14 May 2024
Phase 2
Large B-cell lymphoma
[18F]FDG positron emission tomography (PET)
62
hzludftzgw(tlueeowyhu) = tgfwhgpqnx yupxdflthn (ndmpdwquss )
Positive
14 May 2024
(Non-responders)
hzludftzgw(tlueeowyhu) = uwvlikylrc yupxdflthn (ndmpdwquss )
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Clinical Trial

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Approval

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Regulation

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