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tisagenlecleucel

Trade name: Kymriah

Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Aug 30, 2017

Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer. — Wikipedia

Clinical trial activity

21 trials · 14 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
15
Phase 3
4
Phase 4
0

Earliest trial started Sep 4, 2018 (NCT03630159)

Timeline

2010s

  1. Jan 31, 2014

    Orphan Drug Designation

  2. Aug 30, 2017

    Novartis — Earliest FDA Approval

  3. Aug 30, 2017

    Novartis — NDA Organization

  4. Jan 1, 2018

    Novartis — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2018

    Novartis — Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2018

    Novartis — Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • B-lymphocyte antigen CD19BINDING AGENT

    B-lymphocyte antigen CD19 binding agent

    T-cell immunotherapy. A patients T-cells are extracted and modified with a vector encoding an anti-CD19 chimeric antigen receptor (CAR) to eliminate CD19-expressing malignant and normal cells. The CAR is fused to intracellular signaling domains that initiate and enhance T-cell activity.

Approval history

  • approvedBreakthroughAug 30, 2017

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • tisagenlecleucel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06408194Phase 1May 13, 2024Stanford University
NCT05888493Phase 3Oct 2, 2023Novartis
NCT05633615Phase 2Dec 4, 2022Genentech, National Cancer Institute (NCI), SWOG Cancer Research Network
NCT05460533Phase 2Jul 12, 2022Memorial Sloan-Kettering Cancer Center, Novartis
NCT04890236Early Phase 1 (Phase 1)Feb 1, 2022Emory University, National Cancer Institute (NCI), Novartis, Secura
NCT05075603Phase 1Aug 6, 2021NeoImmuneTech, Inc.
NCT04456023Phase 2May 27, 2021Novartis
NCT04156659Phase 2Sep 22, 2020Novartis
NCT04161118Phase 2Aug 31, 2020Novartis, University of Cologne
NCT04225676Phase 2Feb 28, 2020Novartis
NCT04071366Phase 2Jan 31, 2020Incyte
NCT04234061Phase 2Jan 31, 2020Novartis, Peter MacCallum Cancer Centre
NCT04134117Phase 1Nov 30, 2019Harvard University, Novartis
NCT04094311Phase 3Sep 30, 2019Novartis
NCT03876028Phase 1Jun 11, 2019Novartis
NCT03628053Phase 3Jan 17, 2019Novartis
NCT03568461Phase 2Dec 21, 2018Novartis
NCT03642626Phase 2Dec 18, 2018University of Minnesota
NCT03570892Phase 3Oct 26, 2018Novartis
NCT03610724Phase 2Sep 28, 2018Novartis
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (14)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit161132018
National Cancer Institute (NCI)Government2022022
Emory UniversityAcademic/Hospital1112022
GenentechFor profit1012022
Harvard UniversityAcademic/Hospital1112019
IncyteFor profit1112020
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112022
NeoImmuneTech, Inc.For profit1112021
Peter MacCallum Cancer CentreAcademic/Hospital1112020
SecuraFor profit1012022
Stanford UniversityAcademic/Hospital1112024
SWOG Cancer Research NetworkAcademic/Hospital1112022
University of CologneAcademic/Hospital1112020
University of MinnesotaAcademic/Hospital1112018
14 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDAAug 30, 2017