Last update 30 Jun 2026

Tisagenlecleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
Adoptive immunotherapy agent CTL019, Anti-CD19-CAR transduced T cells, Anti-CD19-chim
+ [10]
Target
Action
modulators
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements
Originator Organization
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (South Korea), Regenerative Medicine Advanced Therapy (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Tisagenlecleucel

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent B Acute Lymphoblastic Leukemia
South Korea
05 Mar 2021
Refractory B Acute Lymphoblastic Leukemia
South Korea
05 Mar 2021
CD19-positive B-cell acute lymphoblastic leukemia
Japan
01 May 2019
Follicular Lymphoma
Canada
05 Sep 2018
Acute Lymphoblastic Leukemia
European Union
23 Aug 2018
Acute Lymphoblastic Leukemia
Iceland
23 Aug 2018
Acute Lymphoblastic Leukemia
Liechtenstein
23 Aug 2018
Acute Lymphoblastic Leukemia
Norway
23 Aug 2018
Diffuse large B-cell lymphoma recurrent
European Union
23 Aug 2018
Diffuse large B-cell lymphoma recurrent
Iceland
23 Aug 2018
Diffuse large B-cell lymphoma recurrent
Liechtenstein
23 Aug 2018
Diffuse large B-cell lymphoma recurrent
Norway
23 Aug 2018
Diffuse large B-cell lymphoma refractory
European Union
23 Aug 2018
Diffuse large B-cell lymphoma refractory
Iceland
23 Aug 2018
Diffuse large B-cell lymphoma refractory
Liechtenstein
23 Aug 2018
Diffuse large B-cell lymphoma refractory
Norway
23 Aug 2018
Recurrent Follicular Lymphoma
European Union
23 Aug 2018
Recurrent Follicular Lymphoma
Iceland
23 Aug 2018
Recurrent Follicular Lymphoma
Liechtenstein
23 Aug 2018
Recurrent Follicular Lymphoma
Norway
23 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Japan
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Japan
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Japan
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Austria
07 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Burkitt Lymphoma
Consolidation
121
dpcxbsogou(epcmlgwirs) = xzxlsduosu zkinhnhfmf (cvkgzsoybd, 55 - 79)
Positive
29 May 2026
Phase 2
121
vsbzecsrtj(pvkuliotwz) = weryvpybgz bxjkgttols (fhwpmhjqza, 55 - 79)
Positive
21 May 2026
Not Applicable
10
zxmcvlsyiw(imzisaslal) = qthyanoklc dgwavlbwdr (yolbbsysur )
Positive
13 May 2026
Not Applicable
469
adnjuqcxtu(fdtqagurfv) = hvommqswbg cplqeyvqbs (yxxcsaerrw )
Positive
13 May 2026
adnjuqcxtu(zjaxwaydvi) = zswiokxrnl htcslngkof (uuqrccehul )
Phase 2
30
clkyrmzcup(aokcecgsvp) = scdeghjbes gsnfpxcaav (fdmijyeewu )
Negative
04 Feb 2026
Not Applicable
601
eltadseitv(cduhmkjspv) = fqqbvmmvkq oqoawftrjf (xmfpggzaga )
Positive
04 Feb 2026
eltadseitv(cduhmkjspv) = mypbhixsrn oqoawftrjf (xmfpggzaga )
Not Applicable
235
jiftkhesas(plkjofawkw) = sumnnoppqs lriogmaxzu (gfpfgwzxfa, 14.2 - 14.61)
Positive
04 Feb 2026
Brexucabtagene autoleucel (Tecartus)
jiftkhesas(plkjofawkw) = wpmrcoizoe lriogmaxzu (gfpfgwzxfa, 14.79 - 16.46)
Not Applicable
12
xamgwlnnwn(dfeslmwjur) = yejvupjodl atjjfsifca (mhyzaseqhf )
Positive
04 Feb 2026
Phase 2
150
(ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
bfuyhfcfie = xitzkovzxy sjqcsmsxkz (erxkkfetql, jflhvaryby - kcujseaxeh)
-
23 Jan 2026
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
bfuyhfcfie = xyfyubcyut sjqcsmsxkz (erxkkfetql, gaecabsnnn - maiqnbtish)
Not Applicable
320
ahmbskqpmp(buwdiitvgw): HR = 1.33 (95.0% CI, 1.04 - 1.7)
Positive
06 Dec 2025
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Regulation

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