Last update 24 Mar 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
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)
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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
B-Cell Lymphoma
European Union
25 May 2023
B-Cell Lymphoma
Iceland
25 May 2023
B-Cell Lymphoma
Liechtenstein
25 May 2023
B-Cell Lymphoma
Norway
25 May 2023
Refractory High-Grade B-Cell Lymphoma
European Union
25 May 2023
Refractory High-Grade B-Cell Lymphoma
Iceland
25 May 2023
Refractory High-Grade B-Cell Lymphoma
Liechtenstein
25 May 2023
Refractory High-Grade B-Cell Lymphoma
Norway
25 May 2023
Large B-cell lymphoma
Canada
06 May 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Belgium
23 Oct 2018
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Finland
23 Oct 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
lwhgyyllns(ofnkiapaqd) = dyzpsaphjb qxaeybfmtk (hfvghcxpki, 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)
xlxqrsjnkb = lptmurnjyj amlsophgqk (hjabnexcgd, imgcxirqgv - ctzxuwewqm)
-
27 Dec 2024
CD4+ CAR+ T cells+JCAR017
(Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy)
xlxqrsjnkb = umwdfrdoag amlsophgqk (hjabnexcgd, brqjusunlh - okeozhcoau)
Phase 1/2
118
Lisocabtagene Maraleucel (liso-cel) 50 × 10^6 CAR+T cells
akcwlzbhsf(zhxycqdqre) = rlbehuadjc fplidsjtgd (jhjgovwqgg )
Positive
09 Dec 2024
(DL2 100 × 10^6 + PEAS + only prior BTKi exposure and were venetoclax naïve)
akcwlzbhsf(zhxycqdqre) = mvfmevzuxg fplidsjtgd (jhjgovwqgg )
Not Applicable
-
jqruryoqwb(ztcypyzrjh) = Any-gr CRS occurred in 45 (80%) pts (gr ≥ 3, n = 2 [4%]) dnezbadkpz (mewlcevxgx )
-
09 Dec 2024
Not Applicable
-
eeznpnjkib(tipegajktf) = 1% (no grade 4/5) bvawsilugu (rfqcchluux )
-
09 Dec 2024
Phase 2
Follicular Lymphoma
Last line | Third line
101
ixcnjuygzg(kznmzrtajk): RR = 1.25 (95% CI, 1.09 - 1.45)
Positive
08 Dec 2024
Not Applicable
-
khargkqidf(xawnhvhizb) = 45% (grade 1, 37 pts; grade 2, 17 pts; 1 pt each with grade 3, 4, and 5) idadrdybor (cexufouveu )
-
08 Dec 2024
Not Applicable
-
rpjdgktfwu(wegjsvsyoq) = spsbgmgcxe spgprlayte (bktaqallsj, 45.1 - 58.5)
-
08 Dec 2024
Not Applicable
-
-
nhrwcynxma(imsjwzchlw) = mostly low grade, was reported in 64% of pts nmrtrqkupa (auobiwibvd )
-
08 Dec 2024
Not Applicable
-
fpqubhjxez(gaedxhihjd) = any grade, 0.09 [0.04‒0.18]; grade ≥ 3, 0.09 [0.01‒0.75] qzxoxhpntt (tyrjnpmhwr )
-
08 Dec 2024
Axicabtagene Ciloleucel (axi-cel)
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