SAR443579

DRUG3 trials

Sponsors

Sanofi-Aventis Recherche & Developpement, Sanofi

Conditions

Acute Lymphocytic LeukaemiaAcute Myeloid Leukaemia RefractoryAcute Myeloid LeukemiaAcute lymphocytic leukaemia- Acute myeloid leukaemia refractory - Myelodysplastic syndrome - Blastic plasmacytoid dendritic cell neoplasiaBlastic Plasmacytoid Dendritic Cell NeoplasiaMyelodysplastic Syndromes

Phase 1

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)

TerminatedNCT05086315

SanofiAcute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Blastic Plasmacytoid Dendritic Cell Neoplasia +1

Start: 2021-12-08End: 2025-06-13Updated: 2025-12-15

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)

CompletedCTIS2023-508357-58-00

Sanofi-Aventis Recherche & DeveloppementAcute lymphocytic leukaemia- Acute myeloid leukaemia refractory - Myelodysplastic syndrome - Blastic plasmacytoid dendritic cell neoplasia

Start: 2022-07-04End: 2025-03-12Target: 57Updated: 2025-06-23

A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies

TerminatedNCT06508489

SanofiAcute Myeloid Leukemia

Start: 2024-08-13End: 2025-08-08Updated: 2025-08-22

Related Papers

Phase 1/2, Open-Label, Multi-Center Study Assessing the Safety, Tolerability and Preliminary Efficacy of CD123 Natural Killer Cell Engager (NKCE), SAR443579, in Combination with Venetoclax and Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy

Blood2024-11-05

First-in-Human Study of the CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia or High Risk-Myelodysplasia: Updated Safety, Efficacy, Pharmacokinetics and Pharmacodynamics

Blood2023-11-0218 citations

P494: A FIRST-IN-HUMAN STUDY OF CD123 NK CELL ENGAGER SAR443579 IN RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA OR HIGH RISK-MYELODYSPLASIA

HemaSphere2023-08-012 citations

A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia.

Journal of Clinical Oncology2023-06-0112 citations

An Open-Label, First-in-Human, Dose-Escalation Study of SAR443579 Administered As Single Agent By Intravenous Infusion in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-Cell Acute Lymphoblastic Leukemia (B-ALL) or High-Risk Myelodysplasia (HR-MDS)

Blood2022-11-1510 citations