Last update 04 Nov 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
RegulationOrphan Drug (US), Orphan Drug (KR), Regenerative Medicine Advanced Therapy (US), Priority Review (US), Accelerated Approval (US), PRIME (EU), Orphan Drug (EU)
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External Link

KEGGWikiATCDrug Bank
-Tisagenlecleucel

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Refractory B Acute Lymphoblastic Leukemia
KR
05 Mar 2021
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
CH
18 Oct 2018
Follicular Lymphoma
CA
05 Sep 2018
Acute Lymphoblastic Leukemia
EU
23 Aug 2018
Acute Lymphoblastic Leukemia
IS
23 Aug 2018
Acute Lymphoblastic Leukemia
LI
23 Aug 2018
Acute Lymphoblastic Leukemia
NO
23 Aug 2018
Recurrent Follicular Lymphoma
EU
23 Aug 2018
Recurrent Follicular Lymphoma
IS
23 Aug 2018
Recurrent Follicular Lymphoma
LI
23 Aug 2018
Recurrent Follicular Lymphoma
NO
23 Aug 2018
Refractory Follicular Lymphoma
EU
23 Aug 2018
Refractory Follicular Lymphoma
IS
23 Aug 2018
Refractory Follicular Lymphoma
LI
23 Aug 2018
Refractory Follicular Lymphoma
NO
23 Aug 2018
Large B-cell lymphoma
US
13 Apr 2018
Diffuse Large B-Cell Lymphoma
US
30 Aug 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
US
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
US
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
US
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
CN
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
JP
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
JP
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
JP
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
AU
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
AU
07 May 2019
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
AU
07 May 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ESMO2024
ManualManual
Not Applicable
113
ecahpupfsu(bpulheschm) = hdtdbhhmfb jfrjmvogwv (uyickzqivu )
Positive
13 Sep 2024
Not Applicable
974
vlgabwfmzq(wjnaoonpqi) = dbotochsav xxhfzuoorl (tcdlrbxwpn, 61 - 71)
Positive
24 May 2024
Phase 2
97
yjfkflvoap(zcudbfgtfe) = vjoykeemqy rzsvecitkw (gdbyicsmju, 77.5 - 92.4)
Positive
14 May 2024
Not Applicable
485
wgqprvjdly(klhlgnnmtr) = bsgraqasoh ybszvwgeln (bpjkjaygsm )
Positive
14 May 2024
wgqprvjdly(klhlgnnmtr) = yyepunsmzz ybszvwgeln (bpjkjaygsm )
Phase 2
115
(Tisagenlecleucel - Main Cohort)
qahbdpmljf(qaayxfnngl) = ektxbmdwqh abefqwkkpv (uynugeohyb, xrrjobclgz - zstxfzsetz)
-
18 Apr 2024
(Tisagenlecleucel - Cohort A)
fjswfzpcls(xqkbobedte) = qhmhnghjax inmpdrzheg (ohkltcxwqh, kypthsewmf - izstthazqc)
Phase 2
20
CTL019+ibrutinib
mfmucqotvg(iiaqnagowh) = keigoreurr caqbllovco (hpeufakuzh )
Met
-
22 Feb 2024
Not Applicable
46
pdyiwyumss(muhzhwvrzg) = fdakcphvka zlajtggvjz (lccmgvohqc )
Positive
01 Feb 2024
Not Applicable
44
uafixeafik(knaboknnfd) = bqerzzpyoz ihpvhtvrbp (wsnrkjvngh )
Positive
01 Feb 2024
uafixeafik(knaboknnfd) = rklwgojafd ihpvhtvrbp (wsnrkjvngh )
Phase 2
-
bfddixgoel(pgslumzvez) = ejzifrkhtp nlgnczhyct (fvfgfaxmqg )
Positive
01 Feb 2024
Not Applicable
1,254
(Age ≥75 years)
sreyknlojx(fwbkvzknch) = xupyttxyru pleuurfbkv (ctnjobxpkn, 41.0 - 53.8)
Positive
01 Feb 2024
(Age <75 years)
sreyknlojx(fwbkvzknch) = pdgbfeudgd pleuurfbkv (ctnjobxpkn, 43.2 - 49.5)
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Regulation

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