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SMART 101

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Drug Profile

SMART 101

Alternative Names: ProTcells™ (CD7+/CD34-; CD5- cells); ProTcell™; SMART-101

Latest Information Update: 24 Feb 2025

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At a glance

  • Originator Smart Immune
  • Class Antineoplastics; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

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

    Yes - Severe combined immunodeficiency; Acute myeloid leukaemia; Precursor B-cell lymphoblastic leukaemia-lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor B-cell lymphoblastic leukaemia-lymphoma; Severe combined immunodeficiency
  • Clinical Phase Unknown Unspecified

Most Recent Events

  • 07 Dec 2024 Interim adverse events and efficacy data from the phase-I/II ReSET-02 trial in Myelodysplastic syndromes presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
  • 23 Oct 2024 Smart Immune plans the proof-of-concept trials for Soild tumours
  • 16 Oct 2023 Phase-I/II clinical trials in Myelodysplastic syndromes in France (Parenteral) (NCT05768035)

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