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Study on the Safety and Feasibility of CART 19/22 T Cells and CART45RA-NKG2D Cells for Children, Adolescents, and Young Adults with Acute Lymphoblastic Leukemia

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 a type of blood cancer called acute lymphoblastic leukemia (ALL), which can be difficult to treat when it comes back or does not respond to standard treatments. The study is specifically for children, adolescents, and young adults who have this condition. The trial will explore the use of two different cell therapies: CART45RA-NKG2D cells and CART 19/22 T cells. These are special treatments that involve using modified cells to help the body fight the cancer.

The purpose of the study is to assess the safety and feasibility of these treatments. Participants will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will be conducted in different groups, with each group receiving one of the two treatments. The trial will monitor how well the treatments work and how long the modified cells stay in the body. It will also look at the body's response to the treatment, including any changes in the blood and other samples.

The trial aims to provide new insights into treating acute lymphoblastic leukemia in young patients who have limited options. By participating in this study, researchers hope to find more effective ways to manage this challenging condition and improve outcomes for those affected. The study is expected to continue until the end of 2028, with recruitment starting in mid-2024.

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

    Initial assessment

    An initial assessment is conducted to confirm eligibility for the trial. This includes reviewing medical history and current health status.

    Eligibility criteria include being under 30 years old at diagnosis or relapse, having a life expectancy greater than 12 weeks, and meeting specific blood count and organ function requirements.

  2. Step 2

    Lymphoapheresis

    Lymphoapheresis is performed to collect white blood cells. This process involves drawing blood, separating the white blood cells, and returning the remaining blood components to the body.

    Adequate venous access is required for this procedure.

  3. Step 3

    Cell modification

    The collected white blood cells are modified in a laboratory to create CART45RA-NKG2D cells or CART 19/22 T cells, depending on the specific treatment arm.

  4. Step 4

    Pre-treatment evaluation

    A pre-treatment evaluation is conducted to ensure the patient is ready for the infusion. This includes checking overall health and confirming the absence of any contraindications.

  5. Step 5

    Infusion of modified cells

    The modified cells are administered through an intravenous infusion. This process involves slowly introducing the cells into the bloodstream over a period of time.

    The specific type of cells infused depends on the treatment arm: CART45RA-NKG2D cells or CART 19/22 T cells.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests and other evaluations to track the persistence of the modified cells and the patient's response.

    The trial aims to determine the safety and feasibility of the treatment, as well as to evaluate the overall response rate.

  7. Step 7

    End of trial

    The trial is expected to conclude by December 31, 2028. Final assessments will be conducted to gather comprehensive data on the treatment's outcomes.

Who can join the trial?

14 criteria

  • Patients must be younger than 30 years old at the time of diagnosis or relapse.
  • Patients must have a Lansky score (for those under 16 years) or Karnofsky score (for those 16 years and older) of 50 or higher. These scores measure the patient's ability to perform daily activities.
  • Patients should have a life expectancy of more than 12 weeks.
  • Patients must have an absolute neutrophil count (ANC) of at least 500/μL, unless the low count is due to leukemia and can be improved with treatment. Neutrophils are a type of white blood cell important for fighting infections.
  • Patients must have a platelet count of at least 50,000/μL, unless the low count is due to leukemia and can be improved with treatment. Platelets help with blood clotting.
  • Patients must have an absolute lymphocyte count of at least 100/μL. Lymphocytes are a type of white blood cell important for the immune system.
  • Patients must have adequate kidney, liver, lung, and heart function.
  • Patients must have suitable veins for a procedure called lymphoapheresis and no reasons that would prevent this procedure. Lymphoapheresis is a process to collect certain blood cells.
  • Patients with a seizure disorder can participate if their seizures are well controlled with medication.
  • The patient or their legal representative, parent(s), or guardian must be able to provide written informed consent, which means they understand and agree to participate in the study.
  • For ARM A: Patients must have CD19+/- CD22+ B-ALL that has relapsed or is not responding to standard chemotherapy, with no other cure available. Previous treatment with CART CD19 therapy is allowed but not required.
  • For ARM B: Patients must have T-ALL that has relapsed or is not responding to standard chemotherapy, with no other cure available.
  • Patients diagnosed with ALL must be suitable for a type of transplant called allogeneic HSCT and willing to proceed if the CART treatment leads to complete remission and the doctor believes it is the best option. Allogeneic HSCT is a procedure where a patient receives blood-forming stem cells from a donor.
  • For ARM B, there must be a suitable haploidentical donor available. A haploidentical donor is a family member who is a partial genetic match for the patient.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of leukemia that is not specified in the study.
  • Patients who have not experienced a return or worsening of their leukemia after treatment.
  • Patients who are not within the age range of children, adolescents, or young adults.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain treatments recently that could affect the study results.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have a history of severe allergic reactions to components used in the study.
  • Patients who are participating in another clinical trial that could interfere with this study.
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Investigated drugs

  • CART-19/22

    is a type of cell therapy used in the trial for children, adolescents, and young adults with a specific type of leukemia called B cell precursor acute lymphoblastic leukemia (ALL). This therapy involves modifying the patient's own immune cells, called T cells, to better recognize and attack cancer cells that have certain markers, CD19 and CD22, on their surface. The goal is to see if this treatment is safe and can be successfully given to patients whose disease has not responded to other treatments.

  • CART-NKG2D T

    is another cell therapy being tested in the trial for patients with a different type of leukemia known as T-cell acute lymphoblastic leukemia (T-ALL). In this therapy, T cells are modified to target cancer cells with a specific marker called NKG2D. This treatment uses T cells from a donor, rather than the patient's own cells, to see if it can be safely administered and if it can help treat the disease in patients who have not responded to other treatments.

What is already known about the treatment

  • CART-19/22

    This medication is administered through an intravenous infusion and is currently being studied in clinical trials for its safety and feasibility. It is primarily used for treating refractory or relapsed acute lymphoblastic leukemia in children, adolescents, and young adults. The medication works by modifying the patient's own T-cells to target and destroy cancer cells that express CD19 and CD22 proteins. It falls under the pharmacological classification of CAR T-cell therapies, which are a type of immunotherapy designed to enhance the body's immune response against cancer.

  • CART-NKG2D T

    This medication is also given via intravenous infusion and is under investigation in clinical trials to assess its safety and feasibility. It is intended for use in treating refractory or relapsed T-cell acute lymphoblastic leukemia in children, adolescents, and young adults. The mechanism involves engineering T-cells to express the NKG2D receptor, enabling them to recognize and attack cancer cells. This medication is classified as a CAR T-cell therapy, a form of immunotherapy aimed at boosting the immune system's ability to fight cancer.

Investigated diseases

Acute Lymphoblastic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It primarily occurs in children, adolescents, and young adults. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they crowd out healthy blood cells, impairing the body's ability to fight infections and carry oxygen. The condition can be classified into B-cell or T-cell types, depending on the specific lymphocytes involved. Relapsed or refractory cases occur when the disease returns after treatment or does not respond to standard therapies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509723-41-00Protocol codeREALL_ CARTEstimated enrolment10 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

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