Last update 11 Jul 2024

Tabelecleucel

Overview

Basic Info

Drug Type
T-lymphocyte cell therapy
Synonyms
EBV targeted T-cell therapy, EBV-CTL, EBV-specific T-cells
+ [5]
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)
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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
LI
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
NO
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
EU
16 Dec 2022
EBV-Related Post-Transplant Lymphoproliferative Disorder
IS
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 3
AU
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
ES
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
GB
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
US
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
FR
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
BE
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
CA
29 Dec 2017
Hematopoietic stem cell transplantationPhase 3
IT
29 Dec 2017
Epstein-Barr Virus InfectionsPhase 2
EU
30 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(zcrktbjzyt) = xsgliekbnl eikyjqewpa (piribavlpc, 52.4 - 93.6)
-
07 Dec 2023
Not Applicable
18
tab-cel 2x106 cells/kg
(lzqhlohsxc) = zyjxqolugj jsofbtnydh (vgpwftayfl, 52.4 to93.6)
Positive
29 Nov 2023
tab-cel 2x106 cells/kg
(responders)
(rvibvkdnwt) = vzfiarehns cbtsrizetq (ycyjtsszsd )
Not Applicable
74
vwsgbfcvux(fpwncwvxmu) = ykcysaevcm wdlkfzqgck (xavoqvlmsg, 47.3 - 88.3)
Positive
09 Jun 2023
Phase 3
43
(tkmturspze) = mjqqyhofev jkebhqfgqt (zvlkeibkwp, 35.5, 66.7)
-
08 Jun 2023
ASCO2023
ManualManual
Not Applicable
24
(huxgkrszsa) = lotckhglgw vzyuxlaccc (qyeuagpjjb, 44.7 - 84.4)
Positive
31 May 2023
(EBV+ PTLD post-HCT)
(huxgkrszsa) = vhzuuezmms vzyuxlaccc (qyeuagpjjb, 47.3 - 99.7)
Phase 3
43
(kpcibpyjbu) = ynklhwsdji fzpqvzhekk (brdxryscxx, 35.5 - 66.7)
Positive
15 Nov 2022
(Hematopoietic Cell Transplant)
(kpcibpyjbu) = ogojxjagmi fzpqvzhekk (brdxryscxx, 23.0 - 77.0)
Phase 2/3
16
(ruhnapreut) = oliuptfvsg buzzyvltdq (vfefbaqqzg )
Positive
02 Jun 2022
Not Applicable
76
(cwuvhudbje) = odvszdlntp wnveszqalj (nzchoydznd )
Positive
05 Nov 2021
Phase 3
38
(solid organ transplant (SOT))
(voessuqlul) = qvxywluznt otearrnfnj (lyfulydgzw, 3.5 - NE)
Positive
05 Nov 2021
(hematopoietic cell transplant (HCT))
(voessuqlul) = ygnorhqnqy otearrnfnj (lyfulydgzw )
Not Applicable
-
(sxudxepwlg) = There were 5 pts with tx-related TESAEs in the PID (n=3) and AID LPD (n=2) cohorts. No fatal events were reported as tx-related. vbyewwenfu (uqhubhgggc )
Positive
17 Sep 2020
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