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An Open-label, First-in-human, Dose-escalation/Expansion Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Adult and Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

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Trial Profile

An Open-label, First-in-human, Dose-escalation/Expansion Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Adult and Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Oct 2024

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At a glance

  • Drugs IPH 6101 (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes; Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

    • Most Recent Events

    • 30 Sep 2024 Planned number of patients changed from 103 to 169.
    • 30 Sep 2024 Planned End Date changed from 11 Nov 2026 to 15 Oct 2030.
    • 17 Jun 2024 Results presented in an Innate Pharma media release. These result data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial.

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