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Study on the Safety of CD19 CAR-T Cells, Cyclophosphamide, and Fludarabine in Adults with Refractory or Relapsed Acute Myeloid Leukemia Expressing CD19

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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 a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in patients whose disease has returned or did not respond to previous treatments. The study is investigating a new treatment using a special type of immune cell therapy known as CD19 CAR-T cells. These are a patient's own T-cells, which are a type of white blood cell, that have been modified in a laboratory to better recognize and attack cancer cells. The treatment is given through an infusion, which means it is delivered directly into the bloodstream.

The main goal of the study is to assess the safety and how well patients tolerate the CD19 CAR-T cells treatment. Participants will receive the treatment and be monitored closely to see how their bodies respond. The study will also involve the use of other medications, such as Cyclophosphamide and Fludarabine, which are given to help prepare the body for the CAR-T cell therapy. These medications are administered through injections or infusions.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to gather information over several months to understand the long-term effects and benefits of the therapy. This research is important for developing new treatments for patients with AML who have limited options. Participants will be contributing to valuable research that could improve future cancer treatments.

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

    Initiation of treatment

    Upon joining the study, the patient will begin the treatment process. This involves the administration of medications designed to prepare the body for the main treatment phase.

  2. Step 2

    Administration of cyclophosphamide

    The patient will receive cyclophosphamide, a medication used to suppress the immune system and help prepare the body for the main treatment. This will be given as an intravenous injection or infusion.

  3. Step 3

    Administration of fludarabine

    Following cyclophosphamide, the patient will receive fludarabine. This medication is also administered intravenously and helps further prepare the body by reducing the number of certain blood cells.

  4. Step 4

    Infusion of CAR-T cells

    The main treatment involves the infusion of CAR-T cells. These are specialized cells that have been modified to target and attack cancer cells. The infusion is done intravenously.

  5. Step 5

    Monitoring and follow-up

    After the CAR-T cell infusion, the patient will be closely monitored to assess the treatment's effectiveness and any potential side effects. This includes regular blood tests and health assessments over a period of time.

  6. Step 6

    Evaluation of treatment response

    The patient's response to the treatment will be evaluated at various intervals, including one month, three months, six months, and twelve months after the CAR-T cell infusion. This evaluation will help determine the treatment's success and the patient's overall health status.

Who can join the trial?

18 criteria

  • The patient must be at least 18 years old when signing the consent form.
  • The patient must have a creatinine clearance of at least 40 mL/min. Creatinine clearance is a measure of how well the kidneys are working.
  • The levels of liver enzymes, ALT and AST, should be no more than 2.5 times the normal limit.
  • Total bilirubin should be 1.5 mg/dL or less, except for patients with Gilbert's syndrome, a mild liver condition.
  • The heart's pumping ability, known as cardiac ejection fraction, should be 45% or higher.
  • The patient should not have any significant findings on an electrocardiogram (ECG), a test that checks heart rhythm.
  • The patient should not have any significant pleural effusion, which is fluid around the lungs.
  • The patient should have an oxygen level greater than 92% when breathing room air.
  • Female patients who can have children must have a negative pregnancy test and agree to use effective birth control methods or abstain from heterosexual contact during the study and for one year after receiving the treatment. They must also agree not to breastfeed during this time.
  • Male patients must agree to use a condom during sexual contact with a pregnant woman or a woman who can have children for at least one year after receiving the treatment, even if they have had a vasectomy.
  • The patient must have acute myeloid leukemia (AML) that shows CD19, a specific marker, through a test called flow cytometry.
  • The patient must have relapsed or refractory AML, meaning the disease has not responded to treatment or has returned after treatment.
  • The patient must have an ECOG performance status of less than 2, which means they are able to carry out daily activities with some limitations.
  • The patient should have an estimated life expectancy of more than 2 months.
  • An MRI scan of the brain should show no signs of cancer affecting the central nervous system.
  • Any side effects from previous treatments should be stable and reduced to a mild level, except for non-serious effects like hair loss.
  • The patient should have a platelet count of at least 30,000 per microliter. Platelets are cells that help with blood clotting.
  • The patient should have an absolute lymphocyte count of at least 200 per microliter. Lymphocytes are a type of white blood cell important for the immune system.

Who cannot join the trial?

5 criteria

  • Patients who are under 18 years old.
  • Patients who do not have a type of blood cancer called R/R AML that shows a specific marker called CD19 on their cells.
  • Patients who cannot undergo a test called Flow-cytometry, which is used to check for the CD19 marker on their cells.
  • Patients who are not able to safely receive the treatment being studied, which involves a type of cell therapy called CD19 CAR-T cells.
  • Patients who are part of a vulnerable population that cannot safely participate in the study.
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Investigated drugs

CD19 CAR-T cells are a type of therapy used in this clinical trial. They are specially modified cells that are designed to target and attack cancer cells expressing the CD19 protein. This therapy is being tested for its safety and how well patients can tolerate it, particularly in those with a type of leukemia that has not responded to other treatments or has returned after treatment.

What is already known about the treatment

CD19 CAR-T cells – This medication is administered through an infusion directly into the bloodstream. It is currently being studied in clinical trials, specifically in a phase I/II study, to assess its safety and tolerability. The main therapeutic indication is for patients with refractory or relapsed acute myeloid leukemia (AML) that expresses CD19. The mechanism of action involves genetically modifying a patient's T-cells to express a chimeric antigen receptor (CAR) that targets the CD19 protein on cancer cells, leading to their destruction. It is classified as a form of immunotherapy, specifically a CAR-T cell therapy.

Investigated diseases

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. AML is more common in adults and can vary in its progression and severity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509212-29-01Protocol codeDRI_2021/0578Estimated enrolment5 patientsSponsorCentre Hospitalier Universitaire De Lille

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).