SAR443579 in AML, B-ALL, or MDS

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This study involves taking a study drug called SAR443579. The overall goal of this study is to find out if the study drug is safe and effective at treating adults and children with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL). This is a first-in-human research study. 

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at cancertrials [at] chop.edu or 267-425-5544.

ClinicalTrials.gov Identifier

NCT05086315

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
23-021411
Official Title:
TCD17197: 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 Phase:
Phase I
Phase II
Eligible Age Range:
12 - 99 Years
Gender:
All
Study Categories:

Visit Criteria

As a participant in the research, you will:

  • Receive SAR443579 (study drug) infusions several times during each study cycle
  • Complete frequent clinic visits at CHOP Philadelphia
  • Stay in the hospital for 12 to 16 days after receiving the first dose of the study drug
  • Have frequent blood and urine tests, including research tests to measure study drug levels
  • Have a research electrocardiogram
  • Submit leftover biopsy tissue and/or bone marrow aspirate to the study sponsor for research tests
  • Complete questionnaires (adult participants only)
Leader
Sarah K. Tasian

Sarah Tasian, MD