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Study of CD19-CAR_Lenti, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia or Aggressive B-Cell Lymphomas

Verified siteRegistered drugNo 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 certain types of blood cancers in children and young adults. The diseases being studied are relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and aggressive types of B-cell Non-Hodgkin Lymphoma (B-NHL), which include Diffuse Large B Cell Lymphoma (DLBCL) and Primary Mediastinal B Cell Lymphoma (PML). These are conditions where the cancer has returned after treatment or has not responded to previous treatments.

The study is testing a new treatment called CD19-CAR_Lenti, which involves using the patient's own immune cells, called T-cells, that are modified in the lab to better recognize and attack cancer cells. This treatment is given through an infusion into the bloodstream. In addition to CD19-CAR_Lenti, the study also uses two other medications, Fludarabine Phosphate and Cyclophosphamide, which are types of chemotherapy drugs that help prepare the body to receive the modified T-cells.

The purpose of the study is to find out how safe and effective the CD19-CAR_Lenti treatment is for these types of cancer. Participants will receive the treatment and be monitored over time to see how their cancer responds. The study will look at how well the treatment works in reducing cancer cells and how long the effects last. Participants will have regular check-ups and tests to track their progress and any side effects they might experience. The study aims to determine the best dose of the treatment and to see if it can help achieve remission, which means the cancer is no longer detectable in the body.

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

    Initial assessment

    The initial assessment involves a thorough review of the patient's medical history and current health status. This step ensures that the patient meets the eligibility criteria for the trial, which includes having a diagnosis of CD19 expressing B acute lymphoblastic leukemia (ALL) or diffuse large B-cell lymphoma (DLBCL) or primary mediastinal lymphoma (PML).

  2. Step 2

    Preparation for treatment

    Before the treatment begins, the patient will undergo a process called leukapheresis. This procedure collects white blood cells, which are then modified to create the CD19-CAR_Lenti cells. These cells are designed to target and destroy cancer cells.

  3. Step 3

    Conditioning regimen

    The patient will receive a conditioning regimen to prepare the body for the infusion of the modified cells. This includes the administration of fludarabine phosphate and cyclophosphamide through intravenous use. The specific dosage and duration will be determined by the medical team based on the patient's condition.

  4. Step 4

    Infusion of modified cells

    The patient will receive an infusion of the CD19-CAR_Lenti cells. This is a critical step where the modified cells are introduced into the patient's body to target and eliminate cancer cells.

  5. Step 5

    Monitoring and follow-up

    After the infusion, the patient will be closely monitored for any adverse effects or reactions. Regular follow-up visits will be scheduled to assess the patient's response to the treatment and to evaluate the overall effectiveness of the therapy. The primary focus will be on achieving complete remission and monitoring for minimal residual disease at specified intervals, such as day 28, day 90, and day 180 post-infusion.

  6. Step 6

    Long-term evaluation

    The patient's progress will be evaluated over a longer period to assess relapse rates, overall survival, and disease-free survival. This includes measuring the expansion and persistence of the CD19-CAR_Lenti cells and correlating disease outcomes with any additional treatments received.

Who can join the trial?

8 criteria

  • The patient must have a diagnosis of a type of cancer that shows a specific marker called **CD19**. This includes certain types of leukemia and lymphoma.
  • The patient must be experiencing a **relapse** (cancer has returned) or have a type of cancer that does not respond to treatment (**refractory**).
  • The patient must be between 1 and 25 years old for certain types of leukemia and between 1 and 35 years old for certain types of lymphoma.
  • The patient must have suitable veins for a procedure called **apheresis**, or be eligible for a catheter to be placed for this procedure. Apheresis is a process where blood is taken from the body, a part of it is removed, and the rest is returned to the body.
  • The patient or their legal guardian must give **informed consent** to participate in the study. This means they understand the study and agree to take part. For children 12 years and older, they should also agree verbally if possible.
  • The patient must have a certain level of physical ability, measured by a scale called **Karnofsky** for those over 16 years old, or **Lansky** for those under 16. A score of 60% or higher is required, which means the patient can take care of themselves with some help.
  • If the patient can have children, they must agree to use **birth control** during the study and for four months after the treatment to prevent pregnancy.
  • Females who can have children must have a **negative pregnancy test** before starting the study to ensure they are not pregnant, as the treatment could harm a developing baby.

Who cannot join the trial?

6 criteria

  • Patients who do not have **relapsed/refractory CD19+ Acute Lymphoblastic Leukemia** or **Diffuse Large B Cell Lymphoma** or **Primary Mediastinal B Cell Lymphoma** cannot participate. These are specific types of blood cancers.
  • Patients who are not within the age range specified for the study. The study is for certain age groups, so if a patient is too young or too old, they may not be eligible.
  • Patients who are not able to follow the study procedures or who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding may not be eligible, as the study may involve risks to the baby.
  • Patients who have participated in another clinical trial recently may not be eligible, as this could affect the study results.
  • Patients who have certain health conditions that could make the study unsafe for them.
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Investigated drugs

CD19-CAR_Lenti is a type of therapy that uses specially modified T cells to target and attack cancer cells. In this trial, the T cells are engineered to express a receptor that specifically recognizes the CD19 protein found on the surface of certain cancer cells, such as those in Acute Lymphoblastic Leukemia and some types of lymphoma. The goal of this therapy is to help the immune system identify and destroy these cancer cells more effectively. The treatment is administered to pediatric patients who have not responded to other treatments or whose cancer has returned.

What is already known about the treatment

CD19-CAR_Lenti – This medication is administered through infusion, specifically targeting pediatric patients with relapsed or refractory CD19-positive Acute Lymphoblastic Leukemia and certain types of B-cell lymphomas. Currently, it is being studied in clinical trials to assess its safety and effectiveness. The main therapeutic indications include treating these specific types of leukemia and lymphomas. At the molecular level, the medication works by using genetically modified T cells that express a chimeric antigen receptor (CAR) targeting the CD19 protein on cancer cells, leading to their destruction. 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 cells.

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 called lymphoblasts. It progresses rapidly, leading to an accumulation of these cells in the bone marrow, which interferes with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system.

  • Diffuse Large B-Cell Lymphoma

    This is a common type of non-Hodgkin lymphoma that originates in the B cells, a type of white blood cell responsible for producing antibodies. It typically presents as a rapidly growing mass, often in the lymph nodes, but it can also occur in other organs. The disease progresses quickly and can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. It can spread to other parts of the body, including the bone marrow and central nervous system.

  • Primary Mediastinal B-Cell Lymphoma

    This is a subtype of diffuse large B-cell lymphoma that primarily affects the mediastinum, the area in the chest between the lungs. It often presents as a large mass in the chest, which can cause symptoms such as cough, chest pain, and difficulty breathing. The disease progresses rapidly and can spread to other areas, including the lymph nodes and other organs. It is more commonly diagnosed in young adults, particularly women.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-519174-39-00Protocol codeCD19-CAR_LentiEstimated enrolment32 patientsSponsorOspedale Pediatrico Bambino Gesu

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