CDEK
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Brexucabtagene autoleucel

Trade name: Tecartus

Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Jul 24, 2020

Clinical trial activity

16 trials · 15 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
10
Phase 3
0
Phase 4
0

Earliest trial started Sep 15, 2017 (NCT03131934)

Timeline

2010s

  1. Apr 20, 2016

    Orphan Drug Designation

  2. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Jul 24, 2020

    Gilead Sciences — Earliest FDA Approval

  2. Jul 24, 2020

    Gilead Sciences — NDA Secondary Org

  3. Jul 24, 2020

    Gilead Sciences — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughJul 24, 2020

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • autologous ebv-ctl transduced with control vector sfg-cna8
  • autologous ebv-ctl transduced with vector sfg-cna12

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06553872Phase 2Aug 23, 2024Bankhead-Coley Florida Biomedical Research Program, Eli Lilly, University of South Florida
NCT06287229Phase 1/Phase 2 (Phase 2)Jul 11, 2024University of Texas at Houston
NCT06253663Phase 2Mar 18, 2024Gilead Sciences
NCT06482684Phase 2Feb 15, 2024Johannes Gutenburg University, Ludwig Maximilians University
NCT06144606Phase 2Nov 15, 2023Gilead Sciences, University of South Florida
NCT05495464Early Phase 1 (Phase 1)Nov 18, 2022Acerta Pharma, Gilead Sciences, University of Texas at Houston
NCT05537766Phase 2Nov 1, 2022Gilead Sciences
NCT05041309Phase 2Nov 30, 2021Gilead Sciences
NCT04880434Phase 2Apr 27, 2021Gilead Sciences
NCT04250324Phase 1Nov 19, 2019Chinese Academy of Medical Sciences, Shanghai Cell Therapy Group Co.,Ltd, Tianjin Medical University
NCT03642626Phase 2Dec 18, 2018University of Minnesota
NCT03624036Phase 1/Phase 2 (Phase 2)Oct 31, 2018Gilead Sciences
NCT04067414Phase 1Jun 14, 2018Chinese Academy of Medical Sciences, Shanghai Cell Therapy Engineering Research Institute
NCT03131934Early Phase 1 (Phase 1)Sep 15, 2017bluebird bio, University of London
NCT05776134N/A—Gilead Sciences
NCT04162756N/A—Gilead Sciences
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (15)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit9732018
Chinese Academy of Medical SciencesAcademic/Hospital2112018
University of South FloridaAcademic/Hospital2212023
University of Texas at HoustonAcademic/Hospital2222022
Acerta PharmaFor profit1012022
Bankhead-Coley Florida Biomedical Research ProgramGovernment1012024
bluebird bioFor profit1012017
Eli LillyFor profit1012024
Johannes Gutenburg UniversityAcademic/Hospital1012024
Ludwig Maximilians UniversityAcademic/Hospital1112024
Shanghai Cell Therapy Engineering Research InstituteAcademic/Hospital1012018
Shanghai Cell Therapy Group Co.,LtdFor profit1112019
Tianjin Medical UniversityAcademic/Hospital1012019
University of LondonAcademic/Hospital1112017
University of MinnesotaAcademic/Hospital1112018
15 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA2Jul 24, 2020
Gilead SciencesFor profitNDAJul 24, 2020