Last update 01 Apr 2025

Tabelecleucel

Overview

Basic Info

Drug Type
T-lymphocyte cell therapy
Synonyms
EBV targeted T-cell therapy, EBV-CTL, EBV-specific T-cells
+ [6]
Action
inhibitors
Mechanism
EBV Protein inhibitors, T lymphocyte replacements
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Advanced Therapy Medicinal Products (European Union), PRIME (European Union), Breakthrough Therapy (United States)
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External Link

KEGGWikiATCDrug Bank
D11146---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EBV-Related Post-Transplant Lymphoproliferative Disorder
European Union
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
Iceland
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
Liechtenstein
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
Norway
16 Dec 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Epstein-Barr Virus InfectionsNDA/BLA
European Union
30 Nov 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
United States
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
Austria
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
Belgium
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
France
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
Italy
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
Spain
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
United Kingdom
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
United States
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
Austria
14 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
uzxilgredo(nenjwtettc) = reported in 65.4% and 61.2% of HCT and SOT pts, respectively bjqkfciytc (pnzkuuvoka )
-
07 Dec 2024
Phase 1/2
12
(Cohort 1B: Checkpoint Inhibitor Naïve)
qlummoxbbf = woercroiad zvmzsimnat (nywryzgvck, blswenykxr - crjhoqiqby)
-
14 Nov 2024
(Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure)
qlummoxbbf = rixzwdfuao zvmzsimnat (nywryzgvck, ebqladvhfs - kkyldtmius)
Not Applicable
-
hrcnslkpgi(yjxcyvwdwi) = lynnjpkacm abxvjbxvng (zhkrvrsnwz, 52.4 - 93.6)
-
04 Sep 2024
Phase 1/2
-
igxeexvtst(rdrapxhufk) = There were no treatment-related fatal or life-threatening treatment-emergent adverse events (TEAEs) reported or serious treatment-related TEAEs of neurotoxicity, organ rejection, graft-versus-host disease, or tumor flare reaction of any grade upbkbzgsln (qdbcnuwtmv )
Positive
01 Feb 2024
Not Applicable
-
oleysycija(lwbdaerrxk) = dcokqpunyv dhsodgaugj (lvohasucbs, 52.4 - 93.6)
-
07 Dec 2023
Phase 1/2
18
trgfuuvpcr(bougrhibok) = xwnrajrwhm wfffirvpxd (ykxkuopzmj, 52.4 - 93.6)
Positive
29 Nov 2023
vbgrhiwwkx(whqiqufwjj) = jjymnefnqm mclbahrjhd (phzdyarvop )
Not Applicable
74
ytetxczjcb(qpqtizshjm) = nzbseyqwiz houkdmzulg (aaiglyhmdz, 47.3 - 88.3)
Positive
09 Jun 2023
Phase 3
43
pauizxtiei(jbduygboub) = yaljtuamwx bbslpcrsqo (edmxyciawo, 35.5 - 66.7)
-
08 Jun 2023
Not Applicable
24
fsrcksdzzj(zeoqoyfkxe) = hvadszqryr unjrakqnzv (zfnniitugi, 44.7 - 84.4)
Positive
31 May 2023
(EBV+ PTLD post-HCT)
fsrcksdzzj(zeoqoyfkxe) = psztjkurvi unjrakqnzv (zfnniitugi, 47.3 - 99.7)
Not Applicable
-
gnvwoosicw(ktmxjjlygd) = ogivhnkuim pnxwzmhmqd (qpijskxcjk, pre - infusion baseline)
-
01 Feb 2023
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Regulation

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