NCT05086315

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult 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)

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: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

Detailed description

Study duration per participant is 2.5 years.

Conditions

• Acute Lymphocytic Leukaemia
• Acute Myeloid Leukaemia Refractory
• Myelodysplastic Syndromes
• Blastic Plasmacytoid Dendritic Cell Neoplasia

Interventions

Type	Name	Description
DRUG	SAR443579	Powder for solution for infusion; by IV infusion

Timeline

• Start date: 2021-12-08
• Primary completion: 2025-06-13
• Completion: 2025-06-13
• First posted: 2021-10-20
• Last updated: 2025-12-15

Locations

23 sites across 5 countries: United States, Australia, China, France, Netherlands

Regulatory

• FDA-regulated drug study