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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAR443579 | Other / unclassified | — | Intravenous |