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Study on CD19-CAR T Cells, Fludarabine, and Cyclophosphamide for Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

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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 relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), which can be challenging to treat. The study is testing a new treatment involving special cells known as CD19-CAR T cells. These are a type of cell therapy where T cells, a part of the immune system, are modified to better recognize and attack cancer cells. The specific treatment being tested is called CD19-CAR_Lenti_ALLO, which is a second-generation version of these cells. The trial aims to find out how safe this treatment is and to determine the best dose for children and young adults who have this type of leukemia.

Participants in the study will receive the CD19-CAR_Lenti_ALLO treatment through an injection. Before receiving this treatment, they may also be given other medications, such as Fludara (fludarabine phosphate) and Cyclophosphamide, which are used to prepare the body for the new cells. These medications help to create a suitable environment for the CD19-CAR T cells to work effectively. The study will monitor the participants closely to see how they respond to the treatment and to check for any side effects.

The purpose of this study is to evaluate the safety of the CD19-CAR_Lenti_ALLO treatment and to establish the recommended dose for patients. The trial will also look at how well the treatment works in reducing the cancer cells in the body. Participants will be observed over a period of time to assess the treatment's impact on their health and to gather information that could help improve future treatments for B-ALL. The study is expected to continue until 2027, with recruitment starting in 2024.

The research process

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

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of relapsed or refractory B-cell Acute Lymphoblastic Leukemia and ensuring the presence of CD19-positive cells.
Eligibility criteria include age between 1 and 35 years, previous CD19-directed therapy, and the availability of a fully matched related donor.
Step 2
Lymphodepletion therapy
Before receiving the main treatment, lymphodepletion therapy is administered. This involves the use of two medications: Fludarabine and Cyclophosphamide.
Fludarabine is given as a 50 mg powder for solution, and Cyclophosphamide is provided as a 1 g injection. Both are administered intravenously as a solution for injection or infusion.
Step 3
Cd19-car t cell infusion
The main treatment involves the infusion of CD19-CAR T cells, which are specially modified cells designed to target and destroy cancer cells.
The dosage depends on the donor's HLA-matching. For a fully matched donor, the dose levels are 3.0 x 10^6 or 5.0 x 10^6 cells per kilogram of body weight. For a haploidentical donor, the dose levels are 1.0 x 10^6 or 3.0 x 10^6 cells per kilogram.
Step 4
Monitoring and follow-up
After the infusion, regular monitoring is conducted to evaluate safety and effectiveness. This includes checking for any side effects and assessing the response to treatment.
The primary goal is to ensure safety and determine the appropriate dose. Secondary goals include evaluating the occurrence of any complications and the effectiveness of the treatment in achieving remission.
Step 5
Long-term follow-up
Long-term follow-up is necessary to monitor the patient's health and the persistence of the CAR T cells. This includes regular check-ups and tests to ensure the treatment's success and manage any long-term effects.
Patients are required to use effective contraception for at least 12 months after the infusion to prevent any potential risks associated with the treatment.

Who can join the trial?

12 criteria

The patient must have a diagnosis of **B-cell Acute Lymphoblastic Leukemia** (B-ALL) that has come back or is not responding to treatment.
The patient must be between **1 and 35 years old**.
The patient must have a certain number of **CD19+ cells** in their blood, which are a type of cell related to the leukemia.
If the patient has had a previous treatment targeting CD19, they can still join if:
- The disease is still CD19-positive.
- The required number of CD19+ cells is present.
- At least one month has passed since the last treatment.
- The previous treatment did not cause severe side effects that are still present.
- The patient must not be eligible for other available treatments or have relapsed within 6 months after a specific type of transplant.
- The patient or their legal guardian must give **informed consent** to participate, meaning they understand and agree to the study.
- The patient must be able to perform daily activities to a certain level, measured by a scale called **Karnofsky** for those over 16, or **Lansky** for those under 16.
- Women who can have children must have a **negative pregnancy test** before starting the study and agree to use birth control during and after the study.
- Men who can father children must agree to use **effective birth control** during and after the study.

Who cannot join the trial?

9 criteria

Patients who have a different type of leukemia or cancer that is not the specific type being studied.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients who have an active infection that is not controlled or treated.
Patients who are pregnant or breastfeeding.
Patients who have a serious heart condition that is not stable.
Patients who have a history of another serious illness that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have received certain treatments recently that could affect the study results.
Patients who have a condition that affects their ability to understand or follow the study instructions.

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Ospedale Pediatrico Bambino Gesu'
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Rome, Italy

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Investigated drugs

CD19-CAR T cells: This therapy involves using specially modified immune cells called T cells. These T cells are taken from a donor and are engineered to target a specific protein called CD19 found on the surface of certain cancer cells. The modified T cells, known as CD19-CAR T cells, are then infused into the patient to help the immune system recognize and attack cancer cells. This treatment is being tested for its safety and effectiveness in children and young adults with a type of blood cancer called B-cell Acute Lymphoblastic Leukemia that has not responded to other treatments.

What is already known about the treatment

CD19-CAR T cells – This medication is administered through an infusion, where specially modified T cells are introduced into the patient's bloodstream. Currently, it is being studied in clinical trials for its effectiveness and safety in treating relapsed or refractory B-cell Acute Lymphoblastic Leukemia, particularly in children and young adults. The main therapeutic use is to target and destroy cancerous B cells in this type of leukemia. At the molecular level, these T cells are engineered to recognize and bind to the CD19 protein on the surface of B cells, leading to their destruction. This medication falls under the pharmacological classification of cell-based immunotherapy.

Investigated diseases

B-cell 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 affects B-cells, which are a type of white blood cell responsible for producing antibodies. The disease progresses rapidly, leading to symptoms such as fatigue, fever, and an increased risk of infections due to the lack of healthy blood cells. In relapsed or refractory cases, the leukemia returns or does not respond to initial treatment, making it more challenging to manage. This condition can occur after treatments like stem cell transplantation or in cases where the disease is particularly resistant to standard therapies.