CDEK
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ciltacabtagene autoleucel

Trade name: Carvykti

Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Feb 28, 2022

Clinical trial activity

80 trials · 79 clinical orgs · 1 marketing orgs

Phase 1
49
Phase 2
33
Phase 3
4
Phase 4
1

Earliest trial started Aug 16, 2017 (NCT03274219)

Timeline

2010s

  1. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2019

    Earliest Phase 2 Sponsor(trial)

  4. Feb 1, 2019

    Orphan Drug Designation

2020s

  1. Feb 28, 2022

    Johnson and Johnson — Earliest FDA Approval

  2. Feb 28, 2022

    Johnson and Johnson — NDA Secondary Org

  3. Feb 28, 2022

    Johnson and Johnson — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughFeb 28, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07091370Phase 1Dec 27, 2025China Academy of Chinese Medical Sciences, Juventas Therapeutics, Inc.
NCT07280793Early Phase 1 (Phase 1)Dec 17, 2025Xuzhou Medical University
NCT07093554Phase 1Dec 1, 2025Medical College of Wisconsin
NCT07149857Phase 2Oct 3, 2025—
NCT07045909Phase 2Jun 30, 2025Clinica Universidad de Navarra, PETHEMA Foundation, University of Salamanca
NCT06940297Phase 2Jun 23, 2025Mayo Clinic, National Cancer Institute (NCI)
NCT07248176N/AApr 10, 2025Shanghai Bioray Laboratory Inc., Tongji University
NCT06880393Phase 2Mar 31, 2025China Academy of Chinese Medical Sciences
NCT06826430Phase 1Mar 1, 2025Juventas Therapeutics, Inc.
NCT06793449Phase 2Feb 5, 2025China Academy of Chinese Medical Sciences
NCT06672185Phase 1Feb 1, 2025Third Arc Bio
NCT06626919Phase 1Jan 31, 2025Arcellx, Inc.
NCT06777264Phase 2Jan 15, 2025Zhejiang University
NCT06718244Phase 2Dec 1, 2024Jiao Tong University
NCT06623630Phase 1Nov 30, 2024American Cancer Society, Inc., Cures Within Reach, Washington University in St. Louis
NCT06574126Phase 2Sep 30, 2024PETHEMA Foundation, Universidad Complutense de Madrid, University of Barcelona
NCT06581640Phase 2Sep 24, 2024Xiamen University
NCT06550895Phase 2Sep 16, 2024—
NCT06413498Phase 3Aug 23, 2024Arcellx, Inc., Gilead Sciences
NCT06577025Phase 2Aug 20, 2024—
Showing 20 of 80 trials
Page 1 / 4

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
China Academy of Chinese Medical SciencesAcademic/Hospital9822023
Zhejiang UniversityAcademic/Hospital8722017
Soochow UniversityAcademic/Hospital5332017
Arcellx, Inc.For profit4332019
CARsgen Therapeutics, Ltd.For profit4232017
Chinese Academy of Medical SciencesAcademic/Hospital4322019
People's Liberation Army of ChinaGovernment4222020
Cellular Biomedicine Group Ltd.For profit3122019
Hrain Biotechnology Co., Ltd.For profit3212018
Jiao Tong UniversityAcademic/Hospital3332017
Juventas Therapeutics, Inc.For profit3222024
Gilead SciencesFor profit2222017
Huazhong University of Science and TechnologyAcademic/Hospital2112018
Janssen Pharmaceutica NVFor profit2222021
Mayo ClinicAcademic/Hospital2122019
Nanjing Medical UniversityAcademic/Hospital2122017
PersonGen BioTherapeutics (Suzhou) Co., Ltd.For profit2212018
PETHEMA FoundationAcademic/Hospital2212024
Second Military Medical UniversityGovernment2012019
Shanghai Bioray Laboratory Inc.For profit2212018
79 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
Johnson and JohnsonFor profitNDA2Feb 28, 2022
Johnson and JohnsonFor profitNDAFeb 28, 2022