ClinicalTrials.gov record
Terminated Phase 1Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT05086315

Public ClinicalTrials.gov record NCT05086315. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 4:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT05086315
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
101 participants

Conditions and interventions

Conditions

Not listed

Interventions

Not listed

Eligibility (public fields only)

Age range
1 Year and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 7, 2021
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update posted
Dec 14, 2025

2021 – 2025

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
City of Hope-Site Number:8400002 Duarte California 91010
Emory University School of Medicine- Grady Campus- Site Number : 8400006 Atlanta Georgia 30303
Beth Israel Deaconess Medical Center-Site Number:8400004 Boston Massachusetts 02215
Weill Cornell Medical College-Site Number:8400003 New York New York 10021
Montefiore Hutchinson Campus- Site Number : 8400012 The Bronx New York 10461
The Ohio State University- Site Number : 8400009 Columbus Ohio 43210
Oregon Health and Science University-Site Number:8400011 Portland Oregon 97239
The Children's Hospital of Philadelphia- Site Number : 8400013 Philadelphia Pennsylvania 19104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05086315, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 14, 2025 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05086315 live on ClinicalTrials.gov.

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