Baltaleucel-T

Drug Profile

Baltaleucel-T

Alternative Names: CMD-003; Cytorex-EBV; EBV-specific cytotoxic T-lymphocytes - CAGT/Cell Medica; EBV-specific T-cells - CAGT/Cell Medica; Epstein Barr virus antigen-activated T-cells - CAGT/Cell Medica; Epstein Barr virus-specific cytotoxic T-lymphocytes - CAGT/Cell Medica; Epstein Barr virus-specific T-cells - CAGT/Cell Medica

Latest Information Update: 27 Feb 2017

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At a glance

  • Originator Baylor College of Medicine
  • Developer Baylor College of Medicine; Cell Medica; Center for Cell and Gene Therapy
  • Class Antineoplastics; Cell therapies; T lymphocyte cell therapies
  • Mechanism of Action Cell replacements; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Post-transplant lymphoproliferative disorder; Non-Hodgkin's lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Phase II Diffuse large B cell lymphoma; Hodgkin's disease; Lymphoma; Nasopharyngeal cancer; Post-transplant lymphoproliferative disorder
  • No development reported Epstein-Barr virus infections

Most Recent Events

  • 21 Feb 2017 Baltaleucel-T receives Fast Track designation for Lymphoma [IV,Infusion] (In adolescents, Second-line therapy or greater, In adults) in USA
  • 21 Feb 2017 Baltaleucel-T receives Fast Track designation for Post-transplant lymphoproliferative disorder [IV,Infusion] (In adolescents, In adults, Second-line therapy or greater) in USA
  • 06 Dec 2016 Efficacy data from the phase II CITADEL and phase I GRALE trial in Lymphoma presented at the 58th Annual Meeting and Exposition of the American Society of Haematology (ASH-Hem-2016)
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