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blinatumomab

Trade name: blincyto

mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA

Approved

Dec 3, 2014

Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used for the treatment of Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that specifically targets the CD19 antigen present on B cells. Blinatumomab is given via intravenous infusion. — Wikipedia

Clinical trial activity

136 trials · 102 clinical orgs · 1 marketing orgs

Phase 1
34
Phase 2
96
Phase 3
21
Phase 4
2

Earliest trial started Jun 1, 2004 (NCT00274742)

Timeline

2000s

  1. Jan 1, 2004

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Amgen — Earliest Phase 2 Sponsor(trial)

  3. May 16, 2008

    Orphan Drug Designation

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Dec 3, 2014

    Amgen — Earliest FDA Approval

  3. Dec 3, 2014

    Amgen — Marketing Organization

  4. Dec 3, 2014

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAcceleratedBreakthroughDec 3, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
Yes

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • antibody mt-103
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blinatumomab
  • blincyto
  • blincyto
  • blincyto
  • medi-538
  • medi-538
  • medi-538
  • mt 103
  • mt-103
  • mt-103
  • mt-103
  • mt-103 antibody
  • mt103 cpd
  • n,n-dicyclohexyl-isoborneol-10-sulfonamide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07283640Phase 1May 18, 2026Amgen, Syndax Pharmaceuticals, University of Texas at Houston
NCT07227584Phase 2Apr 30, 2026Harvard University
NCT07294677Phase 1/Phase 2 (Phase 2)Mar 17, 2026University of Chicago
NCT07301424Phase 2Mar 1, 2026Amgen, University of Alberta
NCT07222579Phase 2Feb 28, 2026Amgen, West Virginia University
NCT07153796Phase 2Feb 28, 2026Amgen, University of Texas at Houston
NCT07192237Phase 2Feb 27, 2026Amgen, University of Texas at Houston
NCT07178912Phase 2Feb 27, 2026Amgen, Ascentage Pharma Group Inc., University of Texas at Houston
NCT07223190Phase 3Jan 30, 2026Amgen
NCT07297914Phase 2/Phase 3 (Phase 3)Jan 15, 2026Bambino Gesù Hospital and Research Institute
NCT07052370Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07133997Phase 1Nov 26, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07134088Phase 1/Phase 2 (Phase 2)Nov 21, 2025Amgen
NCT06991920N/ASep 30, 2025China Academy of Chinese Medical Sciences, People's Liberation Army of China
NCT06930105Phase 2Sep 1, 2025Jiao Tong University
NCT07199855Phase 2Jun 1, 2025Zhejiang University
NCT06985485Phase 2May 17, 2025Soochow University
NCT06882057Phase 2/Phase 3 (Phase 3)Mar 3, 2025China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences
NCT06836973Phase 2/Phase 3 (Phase 3)Mar 1, 2025Capital Medical University
NCT07003737N/AFeb 5, 2025Zhejiang University
Showing 20 of 136 trials
Page 1 / 7

Organizations

Research & Development (102)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit542752004
National Cancer Institute (NCI)Government141132013
University of Texas at HoustonAcademic/Hospital141322011
Zhejiang UniversityAcademic/Hospital8832023
China Academy of Chinese Medical SciencesAcademic/Hospital6632024
Soochow UniversityAcademic/Hospital6622022
St. Jude Children's HospitalAcademic/Hospital5522016
J. W. Goethe UniversityAcademic/Hospital4412017
City of Hope National Medical CenterAcademic/Hospital3222016
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital3322016
Jiao Tong UniversityAcademic/Hospital3322024
Chinese Academy of Medical SciencesAcademic/Hospital2012025
ECOG-ACRIN Cancer Research GroupAcademic/Hospital2012013
Fujian Medical UniversityAcademic/Hospital2022022
Harvard UniversityAcademic/Hospital2212016
Johns Hopkins UniversityAcademic/Hospital2112017
Medical College of WisconsinAcademic/Hospital2212020
MedImmuneFor profit2222007
MerckFor profit2022017
NovartisFor profit2122019
102 organizations
Page 1 / 6

Marketing (2)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGDec 3, 2014
AmgenFor profitNDADec 3, 2014