First-in-Human Study of SAR443579 Infusion in Children and Adults with Certain Types of Blood Cancer

Sponsor: Sanofi

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05086315

Provider View

This clinical trial is testing a new drug, SAR443579, to see if it is safe and effective in treating children and adults with specific types of blood cancers that have returned or not responded to treatment.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new drug called SAR443579 in treating various blood cancers, including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), high-risk myelodysplasia (HR-MDS), and blastic plasmacytoid dendritic cell neoplasm (BPDCN). The trial is open to both children and adults whose cancer has come back or hasn't responded to other treatments. The study will help determine the best dose and how the drug works in the body.

Description

The trial is divided into two parts: Phase 1 and Phase 2. It will last about 2.5 years and will take place at multiple centers. The study aims to find the safest and most effective dose of SAR443579 and to understand how it affects the body and the cancer. Participants will receive the drug through an infusion and will be monitored closely for any side effects and changes in their cancer.

The study is open to children and adults with specific types of blood cancer that have not responded to standard treatments or have returned after treatment. Participants will be divided into different groups based on their age and type of cancer. The trial will help researchers learn more about how SAR443579 can be used to treat these challenging conditions.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 1 year old.
  • Adults aged 12 and older, and children aged 1 to 17.
  • Diagnosed with certain types of blood cancer, such as AML (except APL and JMML), B-ALL, HR-MDS, or BPDCN.
  • Cancer must have returned or not responded to previous treatments.
  • For adults, must have a specific marker called CD123+.
  • Must weigh at least 10 kg.
  • Must not have any available treatments with known benefits.
  • Must provide a signed informed consent form.

Exclusion Criteria

  • Poor overall health or performance status.
  • Recent or ongoing autoimmune diseases requiring treatment.
  • History of other invasive cancers needing active treatment.
  • Active central nervous system leukemia, except in certain cases for children.
  • Active infections like HIV, hepatitis B or C, or COVID-19.
  • Previous treatment with anti-CD123 drugs, except for certain cases in children.
  • Recent stem cell transplant or CAR-T therapy, unless specific conditions are met.
  • Use of certain medications or treatments that could interfere with the study.
  • Pregnant or breastfeeding women.
  • History of solid organ transplant.
  • Certain heart conditions or abnormal heart rhythms.
  • Specific inherited bone marrow failure syndromes in children, except Down syndrome with adequate organ function.

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