Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: 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)
Study ID: NCT05086315
Interventions
Study Description
Brief 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: 2.5 years.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope-Site Number:8400002, Duarte, California, United States
Emory University-Site Number:8400006, Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center-Site Number:8400004, Boston, Massachusetts, United States
Montefiore Medical Center-Site Number:8400012, Bronx, New York, United States
Weill Cornell Medical College-Site Number:8400003, New York, New York, United States
The Ohio State University Comprehensive Cancer Center Site Number : 8400009, Columbus, Ohio, United States
Oregon Health and Science University-Site Number:8400011, Portland, Oregon, United States
Children's Hospital of Philadelphia-3401 Civic Center Blvd Site Number : 8400013, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center-Site Number:8400001, Houston, Texas, United States
Seattle Childrens Hospital and Regional Medical Center Site Number : 8400014, Seattle, Washington, United States
Investigational Site Number :0360002, Melbourne, Victoria, Australia
Investigational Site Number :0360001, Melbourne, Victoria, Australia
Investigational Site Number : 1560001, Tianjin, , China
Investigational Site Number : 1560003, Zhengzhou, , China
Investigational Site Number :2500002, Marseille, , France
Investigational Site Number :2500001, Paris, , France
Investigational Site Number : 2500004, Paris, , France
Investigational Site Number :2500003, Villejuif, , France
Investigational Site Number :5280002, Amsterdam, , Netherlands
Investigational Site Number :5280003, Groningen, , Netherlands
Investigational Site Number : 5280005, Nijmegen, , Netherlands
Investigational Site Number :5280001, Rotterdam, , Netherlands
Investigational Site Number :5280004, Utrecht, , Netherlands
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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