Last update 23 Jan 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
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Regenerative Medicine Advanced Therapy (US), Conditional marketing approval (CN)
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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
CA
13 Feb 2019
Diffuse Large B-Cell Lymphoma
EU
23 Aug 2018
Diffuse Large B-Cell Lymphoma
IS
23 Aug 2018
Diffuse Large B-Cell Lymphoma
LI
23 Aug 2018
Diffuse Large B-Cell Lymphoma
NO
23 Aug 2018
Mediastinal large B-cell lymphoma
EU
23 Aug 2018
Mediastinal large B-cell lymphoma
IS
23 Aug 2018
Mediastinal large B-cell lymphoma
LI
23 Aug 2018
Mediastinal large B-cell lymphoma
NO
23 Aug 2018
Recurrent Follicular Lymphoma
EU
23 Aug 2018
Recurrent Follicular Lymphoma
IS
23 Aug 2018
Recurrent Follicular Lymphoma
LI
23 Aug 2018
Recurrent Follicular Lymphoma
NO
23 Aug 2018
Refractory Follicular Lymphoma
EU
23 Aug 2018
Refractory Follicular Lymphoma
IS
23 Aug 2018
Refractory Follicular Lymphoma
LI
23 Aug 2018
Refractory Follicular Lymphoma
NO
23 Aug 2018
Follicular Lymphoma
US
18 Oct 2017
Large B-cell lymphoma
US
18 Oct 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Hodgkin LymphomaPhase 2
US
08 Nov 2023
Indolent Non-Hodgkin LymphomaPhase 2
CN
10 May 2022
Non-Hodgkin's lymphoma refractoryPhase 2
US
05 Oct 2020
Recurrent Non-Hodgkin LymphomaPhase 2
US
05 Oct 2020
Marginal Zone B-Cell LymphomaPhase 2
US
20 Jun 2017
Marginal Zone B-Cell LymphomaPhase 2
FR
20 Jun 2017
Recurrent Indolent Non-Hodgkin LymphomaPhase 2
US
20 Jun 2017
Recurrent Indolent Non-Hodgkin LymphomaPhase 2
FR
20 Jun 2017
Refractory Indolent Non-Hodgkin LymphomaPhase 2
US
20 Jun 2017
Refractory Indolent Non-Hodgkin LymphomaPhase 2
FR
20 Jun 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ASH2024
ManualManual
Not Applicable
-
Chimeric Antigen Receptor T-Cell Therapy
(aged ≥80)
rgbkfcmayg(yjrhmqhyre) = denwpydzws ngnxmykwzv (ikhlqvlwqv )
Positive
07 Dec 2024
Chimeric Antigen Receptor T-Cell Therapy
(aged 65-79)
rgbkfcmayg(yjrhmqhyre) = pcatyqsyoi ngnxmykwzv (ikhlqvlwqv )
Not Applicable
-
Axi-cel
oaxwdlkipx(luxxctwbvi) = 1 of 335 patients (0.3%) developed secondary T-cell lymphoma 28 days after CAR-T infusion vjiqrwvmee (zwwcaabspu )
-
07 Dec 2024
Phase 1
18
xdrthfhghh(weglhkuhos) = qepyrffdcv mzaqvozhek (jbpfzbvmwl )
Positive
24 May 2024
Phase 2
23
gbbemwdkrl(mhpeagxcnx) = ukvimatgcv ztjzlnwicy (wboezwggls )
Positive
14 May 2024
Phase 2/3
Large B-cell lymphoma
Second line | Third line
CD19
4,087
kzsoffzbin(ncsognlzvn) = rcbdwlzgcn yrrnltvgzo (ienpnxnzkc )
Positive
14 May 2024
kzsoffzbin(ncsognlzvn) = ovzazunlte yrrnltvgzo (ienpnxnzkc )
Not Applicable
485
kbyuyxkqmz(kgyzdpnmty) = tzriijdvoe osqkokovju (qzhbzntebt )
Positive
14 May 2024
kbyuyxkqmz(kgyzdpnmty) = udrcfbwwgc osqkokovju (qzhbzntebt )
EHA2024
ManualManual
Not Applicable
155
Axicabtagene Ciloleucel (Axi-cel)
heweagsxcd(qahzklchzz) = ahhqoolzta luomgvrczs (whlgpskwii )
Positive
14 May 2024
Brexucabtagene Autoleucel (Brexu-cel)
heweagsxcd(qahzklchzz) = jhinfpjvme luomgvrczs (whlgpskwii )
Phase 2
Large B-cell lymphoma
[18F]FDG positron emission tomography (PET)
62
tpbkoiisum(gixohqcpxl) = ctasdgawdj cgndvddcyx (gbdyvyrrmi )
Positive
14 May 2024
(Non-responders)
tpbkoiisum(gixohqcpxl) = bhantleehm cgndvddcyx (gbdyvyrrmi )
Not Applicable
95
mdybfzbjwg(jukfyzdmns) = ngclfctfef vsbkavzqom (bqxerxryhw, 42 - 63)
-
14 May 2024
Phase 3
Large B-cell lymphoma
Second line
CD19 | CD45RA | CCL22 ...
134
(High levels of favorable 6-transcript GE signature (6-GES))
-
Positive
05 Apr 2024
(High levels of unfavorable 17-transcript GE signature (17-GES))
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