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Study of SAR443579 Infusion for Adults and Children with Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia, HR-MDS, or BPDCN

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves participants who have blood cancers that have either returned after earlier treatment or have not responded to standard therapy. These cancers include acute myeloid leukemia, a fast‑growing disease of the bone‑marrow cells that make red blood cells and some white blood cells; B-cell acute lymphoblastic leukemia, a cancer of the lymphoid cells that normally help fight infection; high risk myelodysplastic syndrome, a condition where the bone marrow produces abnormal blood cells and carries a high chance of turning into leukemia; and blastic plasmacytoid dendritic cell neoplasm, a rare disorder of immune cells. The investigational medicine, identified as SAR443579, is given as a single agent by intravenous infusion (the drug is delivered directly into a vein through a small needle).

The purpose of the trial is to find a safe and effective dose of the new drug for these diseases. Participants first receive gradually increasing amounts of the medication to determine the highest dose that can be tolerated without unacceptable side effects, a process called dose‑escalation. Once a suitable dose is identified, additional participants receive that dose to gather more information on how well the drug works. Throughout the study, participants are monitored with regular medical examinations and laboratory tests to track safety and any signs that the cancer is responding to the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. The participant must provide informed consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of conditions such as relapsed or refractory acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), high-risk myelodysplasia (HR-MDS), or blastic plasmacytoid dendritic cell neoplasm (BPDCN).

  3. Step 3

    Dose escalation phase

    During the dose escalation phase, the participant will receive the medication SAR443579 through an intravenous infusion. The goal is to determine the maximum tolerated dose or maximum administered dose. The frequency and duration of administration will be determined by the study protocol.

  4. Step 4

    Monitoring for side effects

    Participants will be closely monitored for any side effects or dose-limiting toxicities. This monitoring is crucial to ensure the safety and well-being of the participant.

  5. Step 5

    Dose expansion phase

    In the dose expansion phase, the participant will receive the recommended dose for expansion. This phase aims to assess the anti-leukemic activity of SAR443579.

  6. Step 6

    Regular follow-up visits

    Regular follow-up visits will be scheduled to monitor the participant's response to the treatment and to check for any adverse effects. These visits are essential for tracking the progress and effectiveness of the treatment.

  7. Step 7

    Completion of the study

    Upon completion of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Participant must be at least 1 year old. Adults must be at least 12 years old, and children must be between 1 to 17 years old.
  • For the Escalation Part:
    • Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), which is a type of blood cancer, except for specific subtypes like acute promyelocytic leukemia (APL) and juvenile myelomonocytic leukemia (JMML).
    • Participants with AML must meet one of the following:
      • Primary Induction Failure (PIF) AML, meaning the disease did not respond to initial treatment attempts.
      • Early relapse (ER) AML, meaning the disease returned within 6 months after initial treatment.
      • Leukemia in first or higher relapse, meaning the disease has returned after being in remission.
      • For children aged 1 to 17, PIF is defined as the disease not responding after two cycles of treatment.
      • For adults only: Confirmed diagnosis of high-risk myelodysplastic syndrome (HR-MDS), a condition where the bone marrow does not produce enough healthy blood cells, with specific risk categories and no available effective therapy.
      • Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer, without disease outside the bone marrow and no available effective therapy.
      • For the Expansion Part (Adults only):
        • Cohort A: Participants with AML that did not respond to initial treatment or relapsed within 6 months after remission.
        • Cohort B: Participants with AML that relapsed more than 6 months after remission.
        • Body weight must be at least 10 kg.
        • For children and the escalation part only: Confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare type of blood cancer, with relapsed or refractory disease and no available effective therapy.
        • For children and the expansion part only: Cohort C: Participants with AML that have relapsed or have disease resistant or intolerant to available therapies.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not part of the study.
  • Patients who have had a different treatment for their cancer recently.
  • Patients with serious infections that are not controlled.
  • Patients with significant heart problems.
  • Patients with severe liver or kidney issues.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients with a history of allergic reactions to similar treatments.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain blood disorders not related to the study.
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Investigated drugs

SAR443579 is an investigational medication being studied for its potential to treat certain types of blood cancers. It is administered as a single agent through an intravenous infusion. The trial aims to find the most effective and safe dose for both adults and children with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), high-risk myelodysplastic syndrome (HR-MDS), or blastic plasmacytoid dendritic cell neoplasm (BPDCN). The study is divided into two parts: the first part focuses on determining the maximum tolerated dose, while the second part evaluates the medication's effectiveness against leukemia at the recommended dose.

What is already known about the treatment

SAR443579 – This medication is administered through intravenous infusion and is currently being studied in clinical trials. It is being investigated for its potential use in treating relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, high-risk myelodysplastic syndrome, and blastic plasmacytoid dendritic cell neoplasm. The drug works by targeting specific pathways involved in the growth and survival of cancer cells, aiming to inhibit their proliferation. SAR443579 is classified as an investigational anti-cancer agent, and its effectiveness and safety are still under evaluation in medical research.

Investigated diseases

  • Acute Lymphoblastic Leukemia

    A type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. It progresses rapidly, leading to a decrease in the number of healthy blood cells, which can cause symptoms like fatigue, frequent infections, and easy bruising or bleeding.

  • Acute Myeloid Leukemia

    A cancer of the blood and bone marrow that results in the rapid growth of abnormal white blood cells. These cells accumulate in the bone marrow and interfere with the production of normal blood cells, leading to symptoms such as fatigue, fever, and an increased risk of infections.

  • Myelodysplastic Syndrome

    A group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the bone marrow does not produce enough healthy blood cells, leading to symptoms like fatigue, shortness of breath, and a higher risk of bleeding and infections.

  • Blastic Plasmacytoid Dendritic Cell Neoplasm

    A rare and aggressive cancer that originates from a type of immune cell known as plasmacytoid dendritic cells. It often presents with skin lesions and can involve the bone marrow and blood, leading to symptoms such as skin rashes, fever, and swollen lymph nodes.

Trial detailsLast updated 13 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508357-58-00Protocol codeTCD17197Estimated enrolment187 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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