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)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

December 8, 2021

Primary Completion Date

June 13, 2025

Study Completion Date

June 13, 2025

Conditions
Acute Lymphocytic LeukaemiaAcute Myeloid Leukaemia RefractoryMyelodysplastic SyndromesBlastic Plasmacytoid Dendritic Cell Neoplasia
Interventions
DRUG

SAR443579

Powder for solution for infusion; by IV infusion

Trial Locations (24)

3000

Investigational Site Number :0360002, Melbourne

3004

Investigational Site Number :0360001, Melbourne

10021

Weill Cornell Medical College-Site Number:8400003, New York

10461

Montefiore Hutchinson Campus- Site Number : 8400012, The Bronx

13009

Investigational Site Number :2500002, Marseille

19104

The Children's Hospital of Philadelphia- Site Number : 8400013, Philadelphia

30303

Emory University School of Medicine- Grady Campus- Site Number : 8400006, Atlanta

43210

The Ohio State University- Site Number : 8400009, Columbus

75010

Investigational Site Number :2500001, Paris

75019

Investigational Site Number : 2500004, Paris

77030

MD Anderson Cancer Center-Site Number:8400001, Houston

91010

City of Hope-Site Number:8400002, Duarte

94800

Investigational Site Number :2500003, Villejuif

97239

Oregon Health and Science University-Site Number:8400011, Portland

98105

Seattle Children's Hospital- Site Number : 8400014, Seattle

300020

Investigational Site Number : 1560001, Tianjin

450008

Investigational Site Number : 1560003, Zhengzhou

02215

Beth Israel Deaconess Medical Center-Site Number:8400004, Boston

19104-4318

Children's Hospital of Philadelphia-3401 Civic Center Blvd Site Number : 8400013, Philadelphia

1081 HV

Investigational Site Number :5280002, Amsterdam

9713 GZ

Investigational Site Number :5280003, Groningen

6525 GA

Investigational Site Number : 5280005, Nijmegen

3015 CE

Investigational Site Number :5280001, Rotterdam

3584 CS

Investigational Site Number :5280004, Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY