Drug Profile


Alternative Names: CD4+CD127lo/-CD25+ polyclonal Treg adoptive immunotherapy; CD4+CD127lo/-CD25+ polyclonal Tregs; CLBS03; Ex vivo expanded human autologous CD4+CD127lo/-CD25+ polyclonal regulatory T cells; NBS 03; NBS03A; NBS03D; NSB-03; NSB-03A; NSB-03D; Regulatory T cell therapy - Athelos Corporation/Becton, Dickinson and Company; Regulatory T lymphocyte cell therapy - Athelos; T cell replacement therapy - Athelos Corporation/Becton, Dickinson and Company; Treg cells - Caladrius Biosciences

Latest Information Update: 24 Mar 2017

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At a glance

  • Originator Becton, Dickinson and Company
  • Developer Athelos Corporation; Becton, Dickinson and Company; Caladrius Biosciences; Sanford Health; University of California at San Francisco
  • Class Antiasthmatics; Antihyperglycaemics; Regulatory T lymphocyte cell therapies
  • Mechanism of Action T lymphocyte replacements
  • Orphan Drug Status

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

    Yes - Type 1 diabetes mellitus
  • New Molecular Entity No

Highest Development Phases

  • Phase II Type 1 diabetes mellitus
  • Preclinical Asthma
  • Research Transplant rejection
  • No development reported Graft-versus-host disease; Multiple sclerosis; Systemic lupus erythematosus

Most Recent Events

  • 06 Sep 2016 Caladrius Biosciences completes enrolment in the first patient cohort in the T-Rex phase II trial for Type-1 diabetes mellitus in USA
  • 28 Jul 2016 CLBS 03 receives Fast Track designation for Type-1 diabetes mellitus [IV,Infusion] (In adolescents) in USA
  • 16 Jul 2016 No recent reports of development identified for research development in Graft-versus-host-disease in USA (IV, Infusion)
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