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An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

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Trial Profile

An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Apr 2025

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At a glance

  • Drugs SMART 101 (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms ReSET-02
  • Sponsors Smart Immune

Most Recent Events

  • 01 Apr 2025 According to Smart Immune media release, The company is still working to produce additional data from our ReSET-02 clinical trial in adult acute leukemia patients, albeit more slowly.
  • 23 Oct 2024 According to Smart Immune media release, company announced that the recommended dose for its lead candidate, SMART101, has been established following the completion of the ReSET-02 trial phase 1 dose escalation segment. Phase II PoC Randomized segment is starting.
  • 02 May 2024 According to a Smart Immune media release, the company announced the treatment of the first patient in the third and final dose cohort of the dose-escalation stage in its ReSET-02 trial.

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