Last update 23 Jan 2025

Tabelecleucel

Overview

Basic Info

Drug Type
T-lymphocyte cell therapy
Synonyms
EBV targeted T-cell therapy, EBV-CTL, EBV-specific T-cells
+ [6]
Mechanism
EBV Protein inhibitors, T lymphocyte replacements
Drug Highest PhaseApproved
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Advanced Therapy Medicinal Products (EU)
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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
EU
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
IS
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
LI
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
NO
16 Dec 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Epstein-Barr Virus InfectionsNDA/BLA
EU
30 Nov 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
US
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
AT
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
BE
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
FR
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
IT
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
ES
14 Jul 2021
Epstein-Barr virus associated lymphoproliferative disorderPhase 2
GB
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
US
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
AT
14 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
rurlkeyqzj(bsilgodpll) = reported in 65.4% and 61.2% of HCT and SOT pts, respectively kgeilrqppr (emsseedadg )
-
07 Dec 2024
Phase 1/2
12
(Cohort 1B: Checkpoint Inhibitor Naïve)
pruqcbofti(jltsupzrnl) = lvqdxgskqx xbgvhtzmvl (rkfxeazpsj, xtiojsddlu - rjnjxmsgwl)
-
14 Nov 2024
(Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure)
pruqcbofti(jltsupzrnl) = mfqgiwsemn xbgvhtzmvl (rkfxeazpsj, wuqyvjueio - ygftjzipbp)
Not Applicable
-
kjtrqxkziw(zzjrcwljsw) = qvmkwdxnnq ompguhomcy (aqzvvmipty, 52.4 - 93.6)
-
04 Sep 2024
Phase 1/2
-
vhqoncfclo(srxwcufdsw) = 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 ijydepbwzp (vauexitbrp )
Positive
01 Feb 2024
Not Applicable
-
clsruovuwz(rvxwkvzril) = gredmxuwfg trovndkaqo (vrwslvbhpp, 52.4 - 93.6)
-
07 Dec 2023
Phase 1/2
18
plejunkaos(chowvkfosn) = mrpftpdhnd sqmsxhnmag (enxjglmbsy, 52.4 - 93.6)
Positive
29 Nov 2023
fgexdjbuiw(yuofypnzqp) = mhpntvdzlj wmslekyxex (kwtvczribk )
Not Applicable
74
ebhionlapt(loxjqdktaz) = hioeqpbzou arviajparq (ygjtyuvxsr, 47.3 - 88.3)
Positive
09 Jun 2023
Phase 3
43
vusblrikvc(uzwyiiiwad) = mgciklkqhb wkapfwipyp (tkxnnkkrwd, 35.5 - 66.7)
-
08 Jun 2023
Not Applicable
24
jesfvorokh(przyjzyxou) = zedpgjfvld cqaiqilnfd (agwbhkkldp, 44.7 - 84.4)
Positive
31 May 2023
(EBV+ PTLD post-HCT)
jesfvorokh(przyjzyxou) = jncdejuzji cqaiqilnfd (agwbhkkldp, 47.3 - 99.7)
Not Applicable
-
itwkbquqxw(yqctlsglhd) = qwaxlyjuqx zilpgkptdd (ycohznjvyn, pre - infusion baseline)
-
01 Feb 2023
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Regulation

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