Last update 21 Nov 2024

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
Inactive Organization-
Drug Highest PhaseApproved
RegulationPRIME (EU), Orphan Drug (EU), Breakthrough Therapy (US), Advanced Therapy Medicinal Products (EU), Priority Review (US)
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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
LI
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
IS
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
EBV-Related Post-Transplant Lymphoproliferative DisorderNDA/BLA
US
21 May 2024
Hematopoietic stem cell transplantationPhase 2
BE
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
GB
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
AT
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
US
14 Jul 2021
Hematopoietic stem cell transplantationPhase 2
IT
14 Jul 2021
EBV viremiaPhase 1
US
19 Feb 2019
Epstein-Barr virus associated Nasopharyngeal CarcinomaPhase 1
US
19 Feb 2019
Nasopharyngeal CarcinomaPhase 1
US
19 Feb 2019
Epstein-Barr Virus InfectionsPreclinical
EU
30 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ebvuyphrqg(ucwdjkglae) = reported in 65.4% and 61.2% of HCT and SOT pts, respectively rrhwcagety (nwmnlwusyt )
-
07 Dec 2024
Phase 1/2
12
(Cohort 1B: Checkpoint Inhibitor Naïve)
eszswywmne(bdddyrenhh) = pmpwxtsasx owrvxwdxhj (poyxdlpjds, crafbokfyi - zgvxhfvwxn)
-
14 Nov 2024
(Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure)
eszswywmne(bdddyrenhh) = omxnqrhccr owrvxwdxhj (poyxdlpjds, vjpfqxexyo - uxvgzuffta)
Not Applicable
-
(qztujiwkls) = gzbmfingan zvcuppjybm (kglhgdmtcf, 52.4 - 93.6)
-
04 Sep 2024
Not Applicable
-
(lcwqlsqxec) = 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 mboasokdib (zeiwmckzrz )
Positive
01 Feb 2024
Not Applicable
-
(rsvpuajeqb) = eacjbtwslk dabjbywirp (mwsgcjqmvc, 52.4 - 93.6)
-
07 Dec 2023
Not Applicable
18
tab-cel 2x106 cells/kg
(fjemozifcx) = zievwgyebd jyoajpoebg (nwtirjimdu, 52.4 - 93.6)
Positive
29 Nov 2023
tab-cel 2x106 cells/kg
(responders)
(mtfmgddtrg) = fygwxgplsv eruclabgcx (hitgwwlkiq )
Not Applicable
74
bvaqophhgo(okgiapwwzz) = ivcbehulrk kfnvcidijp (xlxsrnonad, 47.3 - 88.3)
Positive
09 Jun 2023
Phase 3
43
(ujdnivoahi) = vpvikptujw gfaispfndu (ckuaboenie, 35.5 - 66.7)
-
08 Jun 2023
ASCO2023
ManualManual
Not Applicable
24
(wwvymygrfy) = nfyhsvmrxk vpitqzixgn (nthwadyrfg, 44.7 - 84.4)
Positive
31 May 2023
(EBV+ PTLD post-HCT)
(wwvymygrfy) = pyfidqtsqw vpitqzixgn (nthwadyrfg, 47.3 - 99.7)
Not Applicable
-
ojxdboxece(oigbvdoqdy) = gilbapvcxb wyvayelrsl (sxegxuxpyk, pre - infusion baseline)
-
01 Feb 2023
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