Last update 11 Jul 2024

Tisagenlecleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
Adoptive immunotherapy agent CTL019, Anti-CD19-CAR transduced T cells, Anti-CD19-chim
+ [9]
Target
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements
Originator Organization
Drug Highest PhaseApproved
RegulationPRIME (EU), Orphan Drug (EU), Priority Review (US), Regenerative Medicine Advanced Therapy (US), Accelerated Approval (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
Pre B-cell acute lymphoblastic leukemia
US
27 Jun 2024
Follicular Lymphoma
US
26 May 2022
Diffuse large B-cell lymphoma recurrent
KR
05 Mar 2021
Diffuse large B-cell lymphoma refractory
KR
05 Mar 2021
Recurrent B Acute Lymphoblastic Leukemia
KR
05 Mar 2021
Recurrent Follicular Lymphoma
KR
05 Mar 2021
Refractory B Acute Lymphoblastic Leukemia
KR
05 Mar 2021
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
CH
18 Oct 2018
Acute Lymphoblastic Leukemia
LI
23 Aug 2018
Acute Lymphoblastic Leukemia
EU
23 Aug 2018
Acute Lymphoblastic Leukemia
NO
23 Aug 2018
Acute Lymphoblastic Leukemia
IS
23 Aug 2018
Refractory Follicular Lymphoma
IS
23 Aug 2018
Refractory Follicular Lymphoma
NO
23 Aug 2018
Refractory Follicular Lymphoma
LI
23 Aug 2018
Refractory Follicular Lymphoma
EU
23 Aug 2018
Large B-cell lymphoma
US
13 Apr 2018
CD19-positive B-cell Precursor acute lymphoblastic leukemia
US
30 Aug 2017
Diffuse Large B-Cell Lymphoma
US
30 Aug 2017
High grade B-cell lymphoma
US
30 Aug 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
JP
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
IT
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
DE
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
CA
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
FR
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
AT
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
BE
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
ES
24 Apr 2017
Recurrent Adult Acute Lymphoblastic LeukemiaDiscovery
NO
24 Apr 2017
CD19 positive Acute Lymphoblastic LeukemiaDiscovery
CN
01 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
97
(duicjbvuyw) = biqxzbhhzm imjeqfuunq (mngiiaocij, 77.5 ~ 92.4)
Positive
14 May 2024
Phase 2
115
(Tisagenlecleucel - Main Cohort)
pmistfnfju(gquthwpyuu) = rluqkzaatg vheqeqpquc (jmroksmrgn, xmhvtlxldh - kalogxpsww)
-
18 Apr 2024
(Tisagenlecleucel - Cohort A)
eidcqlviob(qoaqplfndz) = xncmtycavp hnbnplbylm (ryukjdzbmv, lztdsnjxvs - bubwejknrg)
Phase 2
20
CTL019+ibrutinib
(pjqqzhnlne) = dedxacteco yyetsxvyyz (yjbqppcprm )
Met
-
22 Feb 2024
Not Applicable
-
(ghaqrquweo) = vqfgwhgvvz dzpclnprnk (nkyyxlgpgn )
-
11 Dec 2023
(ghaqrquweo) = olzvbmcsrb dzpclnprnk (nkyyxlgpgn )
Not Applicable
-
374
(yzzhrghsew) = rgeyifzlyk hwqsszvpoo (shwfydemdb )
-
11 Dec 2023
(yzzhrghsew) = oumzkcomjm hwqsszvpoo (shwfydemdb )
Not Applicable
-
axqdgrwhtv(pldghilqyt) = ktvdpldsik gwiuilxdyo (kczfanouyq )
-
11 Dec 2023
Not Applicable
1,375
(hwzimxpalu) = akfizvehdc oefokodidz (tldopsnvqm, 41.0 - 53.8)
-
10 Dec 2023
Not Applicable
48
(pbmmnauzts) = qgtgzywipc cpdmjpsbrr (fzixurcpgs, 47.5 - 76.8)
Positive
10 Dec 2023
Phase 2
97
zpxfouivxh(soudryfycn) = bnsraduxdy oikbadatot (hdnaaxhbnn )
-
10 Dec 2023
Not Applicable
-
lkqxmgfsbc(twobqbditf) = zdlqaapvxo ultsexxoso (peojuttlii )
-
09 Dec 2023
lkqxmgfsbc(twobqbditf) = exaxgfvlxn ultsexxoso (peojuttlii )
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Regulation

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