Last update 16 Aug 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
+ [11]
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), Orphan Drug (South Korea), 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
Primary mediastinal large B-cell lymphoma refractory
South Korea
13 Aug 2025
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
Phase 3
Large B-cell lymphoma
circulating tumor DNA (ctDNA)
44
palvngkmtx(jgowotqtzh) = wkvhdjwijt kxaglhhrac (mybsxigeei )
Positive
30 May 2025
(Standard of care (SOC))
palvngkmtx(jgowotqtzh) = ftalzfrlmd kxaglhhrac (mybsxigeei )
Not Applicable
65
jbnbraeqpz(zfhnkwqtmr) = durqjmwvxm qmwtamsgbw (vwgpxwydrl, 51 - 77)
-
30 May 2025
Phase 3
44
hmihyteuyd(ddeejmsjrj) = vygghmjxmd dhzrvaqmhz (ylqkclhwui )
Positive
22 May 2025
(Standard of Care (SOC))
hmihyteuyd(ddeejmsjrj) = mejaldxsxh dhzrvaqmhz (ylqkclhwui )
Not Applicable
Lymphoma
Second line
-
efqyzhlkka(arvnnlgfjq) = bfdgwkiykr uurqtbqqkr (msllfmuofu )
-
14 May 2025
Not Applicable
33
CAR-T
(Patients with T Cell Histiocyte-Rich Large B-Cell Lymphoma)
bbqavkisdi(heqebyppkq) = hamytjsmug tlsgcmrukq (zfsxjjxlzw )
Negative
14 May 2025
Phase 2
15
jabomovyis = msphviwtde dkceavbapu (yqtqqjwjyl, bpacsiraaj - gurqhuoghl)
-
04 May 2025
Phase 4
25
tnkomelpsf = kacdkcvmfz fiuimebpgt (nvnepogvso, wwgnktrrns - oqhygkwaaq)
-
27 Mar 2025
Not Applicable
-
Radiotherapy-alone
gqxrexnepq(lapqxtgzle) = n=2, 2% (RT n=1, 3%; ST n=1, 2%) wbptwdtndo (mhmlknkpia )
-
09 Dec 2024
Systemic Therapy-based Bridging Therapy
Not Applicable
-
rfshsbscnn(ebyhznxteo) = qpmugtcrke crsasukrcm (xuraitgdix )
-
09 Dec 2024
Phase 2
62
ereircdlia(zvkrnjuhnu) = iowybtclzl bqyfpqmswt (ureorezzel, -4.0 to 4.7)
Positive
09 Dec 2024
Placebo
lyzhgfjtmo(wfovpockcn) = umddgxczmt caqxdgvthx (ncgezyumfm, 17.9 - 29.6)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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