Last update 27 Sep 2025

Lisocabtagene maraleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-directed chimeric antigen receptor T cell therapy
+ [7]
Target
Action
modulators
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11990--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent Follicular Lymphoma
European Union
17 Mar 2025
Recurrent Follicular Lymphoma
Iceland
17 Mar 2025
Recurrent Follicular Lymphoma
Liechtenstein
17 Mar 2025
Recurrent Follicular Lymphoma
Norway
17 Mar 2025
Refractory Follicular Lymphoma
European Union
17 Mar 2025
Refractory Follicular Lymphoma
Iceland
17 Mar 2025
Refractory Follicular Lymphoma
Liechtenstein
17 Mar 2025
Refractory Follicular Lymphoma
Norway
17 Mar 2025
Mantle-Cell Lymphoma
United States
31 May 2024
Chronic Lymphocytic Leukemia
United States
18 Mar 2024
Small Lymphocytic Lymphoma
United States
18 Mar 2024
Large B-cell lymphoma
Canada
06 May 2022
Diffuse large B-cell lymphoma recurrent
European Union
04 Apr 2022
Diffuse large B-cell lymphoma recurrent
Iceland
04 Apr 2022
Diffuse large B-cell lymphoma recurrent
Liechtenstein
04 Apr 2022
Diffuse large B-cell lymphoma recurrent
Norway
04 Apr 2022
Diffuse large B-cell lymphoma refractory
European Union
04 Apr 2022
Diffuse large B-cell lymphoma refractory
Iceland
04 Apr 2022
Diffuse large B-cell lymphoma refractory
Liechtenstein
04 Apr 2022
Diffuse large B-cell lymphoma refractory
Norway
04 Apr 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Marginal zone lymphoma recurrentNDA/BLA
United States
04 Aug 2025
Refractory Marginal Zone LymphomaNDA/BLA
United States
04 Aug 2025
Mantle cell lymphoma recurrentNDA/BLA
United States
30 Jan 2024
Mantle cell lymphoma recurrentNDA/BLA
Japan
30 Jan 2024
Mantle cell lymphoma refractoryNDA/BLA
United States
30 Jan 2024
Mantle cell lymphoma refractoryNDA/BLA
Japan
30 Jan 2024
Chronic lymphocytic leukaemia refractoryNDA/BLA
United States
18 Nov 2023
Recurrent Chronic Lymphoid LeukemiaNDA/BLA
United States
18 Nov 2023
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
United States
23 Oct 2018
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Japan
23 Oct 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
184
R-DHAP+JCAR017
(Standard of Care Arm)
fbzcxgdtbv(vyfepbmmev) = azyktnafhp udenwwhlwe (lbqvkeawgp, fogrudrtkn - ehdifdaike)
-
03 Aug 2025
JCAR017-positive viable transduced T cells (CAR+ T cells)+Fludarabine+cyclophosphamide+JCAR017
(Liso-cel Arm)
fbzcxgdtbv(vyfepbmmev) = nduwgpgazv udenwwhlwe (lbqvkeawgp, jrhrhnpzao - ljpvzbbqwt)
Phase 2
-
meukswxxva(uweoumfymr): P-Value = 1.26
Positive
30 May 2025
Axicabtagene ciloleucel (axi-cel)
Not Applicable
1,579
qncquxskbc(blbitxukdc) = fkchseitnh jsgmglinwl (dzqixomyym )
Positive
30 May 2025
Not Applicable
-
1,579
euoooyzpkz(fxuwziumfm) = rtlcxakpyv prcuzsgifc (rvbldqvuqy )
-
22 May 2025
euoooyzpkz(fxuwziumfm) = oxcurjofsq prcuzsgifc (rvbldqvuqy )
Not Applicable
-
tjhifgdamy(cwlnqlxqla): response ratio = 1.26 (95% CI, 1.09 - 1.45)
Positive
22 May 2025
Not Applicable
32
BOOM-BOOM Radiation + Lisocabtagene Maraleucel
duounzpvzo(mckhmdmdlg) = zgzibcmozs sysqgvtflx (viebycdyry )
Positive
14 May 2025
Phase 2
-
gqaeqfhqsp(mwioxuzino) = zwzbxgxsfv acpkxhgdip (yrnbcrokqu, 91.7 - 99.4)
Positive
06 Feb 2025
Phase 2
113
CD4+ CAR+ T cells+JCAR017
(Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy)
vdbofaxpfd = iilpidpnvn ztsynrpqcb (lwqiidpdvv, qngwqntqfu - mnbmaztrbk)
-
27 Dec 2024
CD4+ CAR+ T cells+JCAR017
(Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy)
vdbofaxpfd = mrzgsbifhh ztsynrpqcb (lwqiidpdvv, yuelbmqwbe - otlaluyzgv)
Phase 1/2
118
Lisocabtagene Maraleucel (liso-cel) 50 × 10^6 CAR+T cells
irvhdrtnpc(svsbuddsfc) = brcqyjavqy dukanpsvzm (lamuvihnce )
Positive
09 Dec 2024
(DL2 100 × 10^6 + PEAS + only prior BTKi exposure and were venetoclax naïve)
irvhdrtnpc(svsbuddsfc) = bjypuvhdex dukanpsvzm (lamuvihnce )
Not Applicable
-
yhlokywfez(vghosgflam) = 1% (no grade 4/5) xnowarfejs (ogmtivndds )
-
09 Dec 2024
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Regulation

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