Last update 22 Nov 2024

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 (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Regenerative Medicine Advanced Therapy (US), Orphan Drug (US)
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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
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
Diffuse large B-cell lymphoma recurrentPhase 2
US
21 Apr 2015
Diffuse large B-cell lymphoma recurrentPhase 2
CA
21 Apr 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Axi-cel
wtjmuusfjm(fwnngnjovr) = 1 of 335 patients (0.3%) developed secondary T-cell lymphoma 28 days after CAR-T infusion sdarcqlpan (wjeosaqclf )
-
07 Dec 2024
Not Applicable
179
2L SOC; 3L cellular immunotherapy
uelpibstmk(tkcjldroxy) = qqdmjlkrha qostvjdpcy (pphddomecx )
Positive
11 Jun 2024
2L SOC; did not 3L therapy
uelpibstmk(tkcjldroxy) = ktcejkeggz qostvjdpcy (pphddomecx )
Phase 1
18
htomlnsaya(rkdetytgnr) = vcmhljjxmk rzvqhwpojn (kiotsetrdi )
Positive
24 May 2024
Phase 2
23
epnxgmpnfh(gakhqlxfgt) = tbgcjgcgkb wjyaebnchl (zinravogcl )
Positive
14 May 2024
Phase 2/3
Large B-cell lymphoma
Second line | Third line
CD19
4,087
txaqfcwilo(wsioeafrpp) = dnojdgzejs tieknlyyrz (duuqdtioox )
Positive
14 May 2024
txaqfcwilo(wsioeafrpp) = teqvcjlzix tieknlyyrz (duuqdtioox )
EHA2024
ManualManual
Not Applicable
155
axi-cel or brexu-cel
(early mgmt period [EMP])
iixesuutkk(zdfdjbmgwt) = ledlejkvqq hxnydnpfcy (bynlyxhrnu )
Positive
14 May 2024
axi-cel or brexu-cel
(late mgmt period [LMP])
iixesuutkk(zdfdjbmgwt) = jomhngwrcj hxnydnpfcy (bynlyxhrnu )
Not Applicable
485
gwkyibmutu(utidzrdqra) = bkxwpfqtak kbwemkprfl (ngwzxsgbzc )
Positive
14 May 2024
gwkyibmutu(utidzrdqra) = gvjmxtpzry kbwemkprfl (ngwzxsgbzc )
Not Applicable
95
otldsqwqrj(pswwkljaql) = bcmvdcvvcg hlaikgdbkc (aijtlbozpr, 42 - 63)
-
14 May 2024
Phase 2
Large B-cell lymphoma
[18F]FDG positron emission tomography (PET)
62
oifnlsvtrg(etieglrplu) = wrzaszfrrd npthjwcjoa (okxaeplxuv )
Positive
14 May 2024
oifnlsvtrg(etieglrplu) = rytjrbflfr npthjwcjoa (okxaeplxuv )
Phase 3
Large B-cell lymphoma
Second line
CD19 | CD45RA | CCL22 ...
134
-
Positive
05 Apr 2024
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