Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of DDCART-CD19 cells with cyclophosphamide and fludarabine for children and young adults (up to 39 years) with recurrent acute leukemia after stem cell transplant

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on patients with Relapsed Acute Leukemia, a condition where blood cancer returns after previous treatment. The study tests a new treatment called DDCART-CD19, which uses specially modified immune cells (T-cells) that have been engineered to target cancer cells displaying a specific marker called CD19. This treatment is being studied in children and young adults whose leukemia has returned after receiving a stem cell transplant from a donor.

Before receiving the DDCART-CD19 cells, patients will undergo preparation treatment with cyclophosphamide and fludarabine phosphate. These medications are given through an intravenous line to help prepare the body for the cell therapy. The treatment involves collecting immune cells from the original stem cell donor, modifying them in a laboratory, and then giving them back to the patient through an intravenous infusion.

The purpose of this study is to determine how well DDCART-CD19 works and how safe it is for treating relapsed leukemia. The study will monitor patients for two years after receiving the treatment to see how their body responds and whether the leukemia stays in remission. Researchers will also track how long the modified cells remain in the patient's blood and how they affect the disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be confirmed based on the presence of CD19-positive acute leukemia that has returned or persisted after previous treatments

    A bone marrow examination will be performed to confirm the presence of specific cancer cells

    Your overall health status will be evaluated using a performance score system

  2. Step 2

    Preparation phase

    You will receive two medications through an intravenous line (IV):

    Fludarabine phosphate - given as an infusion into your vein

    Cyclophosphamide - also given as an infusion into your vein

    These medications help prepare your body for the cell therapy

  3. Step 3

    Cell therapy administration

    You will receive DDCART-CD19 cells through an intravenous infusion

    These are specially modified immune cells designed to target your type of leukemia

    The infusion is given as a single dose

  4. Step 4

    Monitoring period - first month

    Your response to the treatment will be evaluated during the first 30 days after the cell infusion

    Regular blood tests will be performed to monitor your condition

    Your bone marrow will be examined to check for signs of remission

  5. Step 5

    Long-term follow-up

    Your progress will be monitored for up to 2 years after the cell therapy

    Regular checkups will track how long the treatment cells remain in your blood

    The status of your B-cells (a type of immune cell) will be monitored

    Additional bone marrow examinations may be performed to confirm continued remission

Who can join the trial?

8 criteria

  • Age requirement: Between 6 months and 39 years old
  • Must have CD19-positive acute leukemia that has either:
    • Come back after stem cell transplant, or
    • Persisted after previous CAR-T cell therapy
    • Must have at least 0.05% of leukemia cells (CD19+ blast cells) in bone marrow testing, or have disease outside the bone marrow
    • Must not have signs of moderate to severe rejection of transplanted cells (GVHD) for at least 4 weeks without taking immunosuppressive medications
    • Must have good enough physical function, measured by:
      • Lansky score of 50 or higher (for patients under 16 years)
      • Karnofsky score of 50 or higher (for patients 16 years and older)
      • The original stem cell donor must be available

Who cannot join the trial?

15 criteria

  • Active and uncontrolled infections (including bacterial, viral, or fungal infections)
  • Presence of graft-versus-host disease (a condition where transplanted cells attack the recipient's body) requiring systemic therapy
  • Severe heart conditions including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Recent heart attack (within last 6 months)
    • Severe lung disease requiring oxygen therapy
    • Severe kidney problems requiring dialysis
    • Severe liver disease with impaired function
    • Active other types of cancer
    • Pregnancy or breastfeeding
    • Known allergies to study medications
    • Central nervous system involvement (cancer spread to brain or spinal cord)
    • Participation in other clinical trials within past 30 days
    • Mental conditions that prevent understanding of study requirements
    • HIV, active hepatitis B, or active hepatitis C infection
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • DDCAR-CD19

    is a type of CAR T-cell therapy where immune cells (T cells) are taken from stem cell donors and modified to target CD19, a protein found on certain leukemia cells. These modified cells are designed to recognize and fight cancer cells in patients with acute leukemia who have previously received a stem cell transplant. The cells are manufactured using a special device called CliniMACS Prodigy.

  • Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

    is a procedure where healthy blood-forming stem cells from a donor are used to replace the patient's diseased or damaged bone marrow. This treatment is used as a foundation therapy before the CAR T-cell treatment.

What is already known about the treatment

DDCAR-CD19 - A specialized cellular therapy consisting of donor-derived T cells that have been genetically modified to target CD19-positive leukemia cells, specifically designed for patients who have relapsed after stem cell transplantation. This treatment is administered through intravenous infusion and represents an innovative approach in immunotherapy for treating relapsed acute leukemia in children and young adults up to 39 years old. The therapy works by using engineered immune cells (CAR T cells) that are programmed to recognize and attack cancer cells expressing the CD19 protein on their surface, belonging to the class of cellular immunotherapy products manufactured using the CliniMACS Prodigy system.

Investigated diseases

Relapsed Acute Leukemia - A blood and bone marrow cancer that has returned after a period of improvement or remission. The disease occurs when immature blood cells in the bone marrow develop abnormally and multiply uncontrollably. These abnormal cells interfere with the production of normal blood cells and can spread to other parts of the body. During relapse, the symptoms may include fatigue, frequent infections, easy bruising or bleeding, bone pain, and fever. The disease affects both children and adults, with symptoms typically developing rapidly over days or weeks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516091-15-00Protocol codeELPIDA-ALLOCART-01Estimated enrolment8 patientsSponsorNosokomeio Paidon I Agia Sofia

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.