drugset / Trial / 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)

NCT05086315 ↗

Phase 1/2 Terminated 101 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-12-08
Primary completion
2025-06-13
Completion
2025-06-13

Outcome

Outcome not reported

Stopped (Business): “Early discontinuation based on strategic sponsor decision not driven by any safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR443579 Other / unclassified — Intravenous