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Study of Pivekimab Sunirine for Adults with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Blood Cancers

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called Pivekimab Sunirine, also known by its code name IMGN632. The study is aimed at adults with certain types of blood cancers, specifically Acute Myeloid Leukemia and other blood cancers that have a marker called CD123. These types of cancers are known as hematologic malignancies, which means they affect the blood, bone marrow, or lymph nodes.

The purpose of the study is to test how well Pivekimab Sunirine works when given to patients through an intravenous infusion, which means the medicine is delivered directly into the bloodstream. The study will include different phases where the dosage of the medication is adjusted to find the most effective and safe amount. Patients will receive the treatment and be monitored for their response to the medication and any side effects they might experience.

Throughout the study, researchers will observe how the treatment affects the cancer and will also look at the overall response rate, which includes how many patients experience a reduction in cancer symptoms. The study will also assess the safety of the treatment by monitoring any adverse events, which are unexpected medical problems that occur during the study. The goal is to gather information that could lead to better treatment options for patients with these types of blood cancers.

The research process

The trial runs in 6 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, confirmation of CD123 positivity is required. This is done through specific tests that identify the presence of CD123 in the blood.

    Eligibility is determined based on the type of blood cancer and previous treatments. Patients with certain types of leukemia or other blood cancers may be eligible.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of pivekimab sunirine, a medication given through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    The dosage and frequency of the medication are determined by the specific phase of the trial and the patient's condition.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to assess the patient's response to the treatment. This includes blood tests and other evaluations to track the progress of the disease and any side effects.

    The study aims to determine the most effective dose and to evaluate the overall response to the treatment.

  4. Step 4

    Dose escalation phase

    In this phase, the dose of pivekimab sunirine may be gradually increased to find the maximum dose that can be tolerated without severe side effects.

    Patients are closely monitored for any adverse reactions during this phase.

  5. Step 5

    Expansion phase

    This phase involves treating more patients with the dose determined to be effective and safe in the previous phase.

    The goal is to further evaluate the treatment's effectiveness in a larger group of patients.

  6. Step 6

    Completion and follow-up

    After completing the treatment, patients undergo follow-up assessments to monitor long-term effects and overall health.

    The study is expected to continue until the end of 2026, with ongoing evaluations of patient outcomes.

Who can join the trial?

14 criteria

  • Patients must have a confirmed diagnosis of certain blood cancers, such as **Acute Myeloid Leukemia (AML)** or **Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)**, with specific characteristics.
  • Patients who have had a **bone marrow transplant** are eligible, but certain conditions must be met, such as the transplant being done more than 120 days before the study and no active severe **graft versus host disease (GvHD)**.
  • Patients must provide voluntary written consent to participate in the study.
  • Women who can have children must agree to use birth control during the study and for 7 months after the last dose of the study drug.
  • Women must have a negative pregnancy test before starting the study drug.
  • Men who can father children must agree to use birth control during the study and for 4 months after the last dose of the study drug.
  • Patients with a previous cancer are eligible if they do not need current treatment for it and have been in remission for at least 6 months.
  • Patients in certain phases of the study may have had up to 3 previous treatments.
  • Patients must be 18 years or older.
  • Patients must have a good performance status, which means they can perform daily activities with minimal assistance.
  • Any side effects from previous treatments must be mild or resolved.
  • Liver function tests must be within acceptable limits, with some exceptions for patients with liver issues related to their cancer.
  • Kidney function must be above a certain level, measured by **glomerular filtration rate** or **creatinine clearance**.
  • The heart's ability to pump blood, measured by **left ventricular ejection fraction**, must be at least 45%.

Who cannot join the trial?

4 criteria

  • Patients who do not have **Acute Myeloid Leukemia** or other blood cancers cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the gender requirements for the study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection, cannot participate.
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Investigated drugs

IMGN632 is a medication being studied for its potential to treat patients with certain types of blood cancers, specifically those that are CD123-positive. This includes conditions like Acute Myeloid Leukemia (AML) and other similar hematologic malignancies. The medication is administered intravenously, meaning it is given directly into the bloodstream through a vein. The study aims to determine the effectiveness and safety of IMGN632 when used alone, without combining it with other treatments.

What is already known about the treatment

IMGN632 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating acute myeloid leukemia and other blood cancers. It is in the early phases of clinical research, with ongoing studies to determine the appropriate dosage and its impact on specific blood cancers. IMGN632 is designed to target CD123-positive cancer cells, working by binding to these cells and delivering a toxic payload that helps to destroy them. It falls under the pharmacological classification of antibody-drug conjugates, which are engineered to specifically target and kill cancer cells while minimizing damage to healthy cells.

Investigated diseases

  • Acute Myeloid Leukemia

    Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. The disease is more common in adults and can vary in its specific genetic mutations, which may influence its behavior and progression. AML requires prompt medical attention due to its aggressive nature.

  • Blastic Plasmacytoid Dendritic Cell Neoplasm

    Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a rare and aggressive type of blood cancer that originates from plasmacytoid dendritic cells. It often presents with skin lesions, which may appear as bruises or nodules, and can also affect the bone marrow and lymph nodes. BPDCN is characterized by its rapid progression and can lead to symptoms such as fatigue, fever, and weight loss. The disease is more commonly diagnosed in older adults and requires specialized medical evaluation. BPDCN is known for its unique cellular origin and distinct clinical presentation.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514195-40-00Estimated enrolment179 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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