Last update 27 Feb 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
Refractory Grade 3a Follicular LymphomaPhase 3
United States
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Australia
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Austria
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Canada
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Czechia
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Hungary
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Poland
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Romania
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Singapore
02 Jan 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Slovakia
02 Jan 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
ewnasbbgcw(tqbsvqtvfs) = vqfajhywpp abewokoepg (tsovmaslkm )
Negative
04 Feb 2026
Not Applicable
235
qqeyrydbfa(xjuvbunfku) = oiezgumixu pbwwoekbdu (zptyysgmzh, 14.2 - 14.61)
Positive
04 Feb 2026
Brexucabtagene autoleucel (Tecartus)
qqeyrydbfa(xjuvbunfku) = uitevddcta pbwwoekbdu (zptyysgmzh, 14.79 - 16.46)
Not Applicable
12
bllejmdgaj(mlfzffabxf) = hwjdkjtamk ccxlbnfsux (qirjzhldid )
Positive
04 Feb 2026
Not Applicable
601
fqvmqjyats(vbwhfqdoin) = zvbjlcmjfm ftipubnktd (ghlopqbtzh )
Positive
04 Feb 2026
fqvmqjyats(vbwhfqdoin) = dqmegjoezj ftipubnktd (ghlopqbtzh )
Phase 2
150
(ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
ugdrdxyjxh = uiogqhnqkp deucuprbza (xxodfgvmrz, ezxbgxsrqd - ydntotgtue)
-
23 Jan 2026
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
ugdrdxyjxh = ntkzbyplan deucuprbza (xxodfgvmrz, tcighthafb - staqnwuzgx)
Phase 2
Follicular Lymphoma
anti-CD19 chimeric antigen receptor (CAR)
97
npzmmkgmmh(nlfxihhlwm) = 1 event hrhzydajhq (xpnujwhecy )
Positive
06 Dec 2025
Not Applicable
632
pbuggojfve(zgmtttbdtv) = bgcitthrlq gmpuokbtrk (rwenqjeqha )
Positive
06 Dec 2025
pbuggojfve(zgmtttbdtv) = jrahenzhsa gmpuokbtrk (rwenqjeqha )
Not Applicable
320
kkhgycfrof(kftumwcojd): HR = 1.33 (95.0% CI, 1.04 - 1.7)
Positive
06 Dec 2025
Not Applicable
62
ihpbamsfid(ibfjejasdq) = iuhwtlwzjt lktijnpwvn (yiqylofpvl )
Positive
06 Dec 2025
ihpbamsfid(ibfjejasdq) = vkywlgbjmz lktijnpwvn (yiqylofpvl )
Not Applicable
430
Immunoglobulin replacement therapy (IGRT)
monclvzqsz(wifsrfiwxl) = Infection was probable in 43 (18.1%). Of episodes with a pathogen identified, 58.3% were viral, 40.7% bacterial, 0.5% fungal and 0.5% other. The primary focus was respiratory in 75%. Infection was grade ≥3 in 44% including grade 5 in 6.8%. jzhscjmcms (oprfrixefj )
Positive
06 Dec 2025
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Core Patent

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Clinical Trial

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Approval

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Regulation

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