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axicabtagene ciloleucel

Trade name: Yescarta

Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Oct 18, 2017

Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor. The resulting chimeric antigen receptor T cells (CAR-Ts) that react to the cancer are then given back to the person to populate the bone marrow. Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities. — Wikipedia

Clinical trial activity

41 trials · 33 clinical orgs · 2 marketing orgs

Phase 1
12
Phase 2
33
Phase 3
3
Phase 4
1

Earliest trial started Jan 1, 2015 (NCT02348216)

Timeline

2010s

  1. Mar 27, 2014

    Orphan Drug Designation

  2. Jan 1, 2015

    Kite Pharma, Inc. — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2015

    Kite Pharma, Inc. — Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2017

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

  5. Oct 18, 2017

    Kite Pharma, Inc. — Earliest FDA Approval

  6. Oct 18, 2017

    Kite Pharma, Inc. — NDA Organization

  7. Oct 18, 2017

    Gilead Sciences — NDA Secondary Org

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 that encodes an anti-CD19 chimeric antigen receptor (CAR) to bind and eliminate CD19-expressing cancer cells and normal B cell. The CAR is fused to domains that enhance T-cell activity.

Approval history

  • approvedPriority reviewBreakthroughOct 18, 2017

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • axicabtagene ciloleucel
  • kte-c19

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06902012Phase 1/Phase 2 (Phase 2)Feb 28, 2027Southern Medical University
NCT07042438Phase 2Jan 17, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06935136N/AApr 30, 2025Jiao Tong University
NCT06912529Phase 2Mar 13, 2025Gilead Sciences, University of Munster
NCT06826118Phase 2Feb 8, 2025Xiamen University
NCT07254754Phase 2Nov 20, 2024Evidenze Health España (CRO), Gilead Sciences, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, Hospital General Universitario Gregorio Marañon, University of Barcelona, University of Salamanca
NCT06609304Phase 4Sep 30, 2024Zhengzhou University
NCT06550141Phase 2Aug 31, 2024Harvard University, Swedish Orphan Biovitrum
NCT06213311Phase 2May 7, 2024Genentech, Gilead Sciences, University of Texas at Houston
NCT06043323Phase 2Mar 31, 2024University of Texas at Houston
NCT05794958Phase 1May 23, 2023Kite Pharma, Inc., Stanford University
NCT05800067N/AMar 4, 2023Jiao Tong University
NCT05605899Phase 3Feb 28, 2023Gilead Sciences
NCT05633615Phase 2Dec 4, 2022Genentech, National Cancer Institute (NCI), SWOG Cancer Research Network
NCT05641428Phase 2Oct 18, 2022HOVON - Dutch Haemato-Oncology Association, University of Groningen
NCT05371093Phase 3Sep 12, 2022Gilead Sciences
NCT05459571Phase 2Aug 10, 2022Gilead Sciences
NCT05077527Phase 1Jan 31, 2022AIDS Malignancy Consortium, National Cancer Institute (NCI)
NCT05041309Phase 2Nov 30, 2021Gilead Sciences
NCT04608487Phase 1Apr 30, 2021Gilead Sciences, Harvard University
Showing 20 of 41 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit151042017
Kite Pharma, Inc.For profit8732015
National Cancer Institute (NCI)Government4022020
GenentechFor profit3012016
Harvard UniversityAcademic/Hospital3322019
University of Texas at HoustonAcademic/Hospital3312020
Jiao Tong UniversityAcademic/Hospital2212023
Swedish Orphan BiovitrumFor profit2012020
University of WashingtonAcademic/Hospital2212020
AIDS Malignancy ConsortiumAcademic/Hospital1112022
AstraZenecaFor profit1012020
CHU Henri MondorAcademic/Hospital1012021
City of Hope National Medical CenterAcademic/Hospital1112026
Evidenze Health España (CRO)For profit1012024
Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaAcademic/Hospital1112024
Hospital General Universitario Gregorio MarañonAcademic/Hospital1012024
HOVON - Dutch Haemato-Oncology AssociationAcademic/Hospital1012022
HumanigenFor profit1012020
IncyteFor profit1112020
PfizerFor profit1012018
33 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA2Oct 18, 2017
Kite Pharma, Inc.For profitNDAOct 18, 2017