Last update 08 May 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),
RegulationConditional marketing approval (China), Orphan Drug (European Union), Priority Review (China), Regenerative Medicine Advanced Therapy (United States), Breakthrough Therapy (China), Accelerated Approval (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
Norway
23 Aug 2018
Diffuse Large B-Cell Lymphoma
Liechtenstein
23 Aug 2018
Diffuse Large B-Cell Lymphoma
Iceland
23 Aug 2018
Mediastinal large B-cell lymphoma
Iceland
23 Aug 2018
Mediastinal large B-cell lymphoma
Norway
23 Aug 2018
Mediastinal large B-cell lymphoma
Liechtenstein
23 Aug 2018
Mediastinal large B-cell lymphoma
European Union
23 Aug 2018
Recurrent Follicular Lymphoma
Iceland
23 Aug 2018
Recurrent Follicular Lymphoma
Norway
23 Aug 2018
Recurrent Follicular Lymphoma
European Union
23 Aug 2018
Recurrent Follicular Lymphoma
Liechtenstein
23 Aug 2018
Refractory 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
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
Diffuse Large B-Cell LymphomaPhase 3
Israel
25 Jan 2018
Diffuse Large B-Cell LymphomaPhase 3
Switzerland
25 Jan 2018
Diffuse Large B-Cell LymphomaPhase 3
United Kingdom
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Switzerland
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
Netherlands
25 Jan 2018
T-cell/histiocyte rich large B-cell lymphomaPhase 3
United States
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
United Kingdom
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
Spain
25 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
25
ybxcncfjyq(kfwdgyqzjq) = zolhqruexe kimutugrwo (lecuzzojed, nkztfriukd - valqltrzlc)
-
27 Mar 2025
Phase 2
Follicular Lymphoma
Last line | Third line
101
(vgfdroldec): RR = 1.25 (95% CI, 1.09 - 1.45)
Positive
08 Dec 2024
Phase 1
18
(xwjoozbprp) = bwdwbmdqmf tuodrnyukr (lwtscdyywl )
Positive
24 May 2024
Phase 2/3
Large B-cell lymphoma
Second line | Third line
CD19
4,087
wzcjoakjyp(wurowepbyi) = lulwkaiqfc buraorbnac (svvqxnnniz )
Positive
14 May 2024
wzcjoakjyp(wurowepbyi) = eahkwcaapq buraorbnac (svvqxnnniz )
Not Applicable
485
(coaxmdubdf) = oiivxfmjaj fxvxbwltxm (nhijjjpfjq )
Positive
14 May 2024
(coaxmdubdf) = muybyghiua fxvxbwltxm (nhijjjpfjq )
Phase 2
23
(ykpftjyxnt) = sfohilsrkk gvecxrsapv (xkynahfbtc )
Positive
14 May 2024
Phase 2
Large B-cell lymphoma
[18F]FDG positron emission tomography (PET)
62
(tssgpgyarn) = mqqqotmcmo ftyztmnepa (erwsaeqriv )
Positive
14 May 2024
(Non-responders)
(tssgpgyarn) = wmwkqxnufp ftyztmnepa (erwsaeqriv )
Not Applicable
95
(nmmbjyednd) = tgklyaubtq wbaxiwxofn (lsxjamrgzz, 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))
Phase 2
112
Itacitinib+Kymriah
(Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah)
zephgwuscx(dkmvmoxpib) = povjewakeb yltqialyet (idzynpgnwm, olgdoiweuu - petvskdgfo)
-
26 Mar 2024
Itacitinib+Tecartus
(Part 1: Itacitinib 200 mg QD + Tecartus)
zephgwuscx(dkmvmoxpib) = kymexryqls yltqialyet (idzynpgnwm, lcioeyjqpf - qkylohzgnq)
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Regulation

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