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Study of CARCIK-CD19 Cells for Patients with Relapsed or Refractory B Cell Precursor 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 B cell precursor Acute Lymphoblastic Leukemia (BCP-ALL). This disease affects both children and adults and is characterized by the presence of cancerous cells in the bone marrow. The treatment being tested in this study is called PTG-CARCIK-CD19, which involves using special cells known as CARCIK-CD19 cells. These cells are designed to target and fight the cancer cells in the body.

The purpose of the study is to confirm how well patients respond to the treatment after receiving the first infusion of CARCIK-CD19 cells and to see if the response lasts longer. Participants in the study will receive one or two infusions of these cells. The study will monitor the patients' response to the treatment at different points in time, specifically looking at the overall response rate 28 days after the first infusion and the duration of response from day 70 for those who achieve and maintain remission.

Additionally, the study will assess the overall survival of patients, which means the time from receiving the infusion to any potential death. It will also evaluate the safety of administering the CARCIK-CD19 cells, whether they are from a donor (allogeneic), from the patient themselves (autologous), or from cord blood. The study aims to provide valuable information on the effectiveness and safety of this innovative treatment for patients with relapsed or refractory BCP-ALL.

The research process

The trial runs in 6 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 a review of medical history and current health status.
Tests are performed to ensure the absence of severe kidney or liver disease and to confirm the presence of B cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
Step 2
Preparation for infusion
Before receiving the treatment, a detailed explanation of the procedure is provided. Informed consent is obtained from the patient or guardian.
The patient must not be taking any immunosuppressive agents for at least 30 days prior to the infusion.
Step 3
First infusion
The first infusion of PTG-CARCIK-CD19 cells is administered. This is a suspension for injection given through an infusion.
The goal is to confirm a high overall response rate by day 28 after this infusion.
Step 4
Monitoring and evaluation
After the first infusion, the patient's response is monitored closely. This includes regular health check-ups and tests to assess the effectiveness of the treatment.
The primary focus is on the overall response rate at 28 days and the duration of response from day 70 for those who achieve and maintain remission.
Step 5
Second infusion (if applicable)
If necessary, a second infusion of PTG-CARCIK-CD19 cells may be administered. The safety of this second administration is carefully evaluated.
The decision for a second infusion is based on the patient's response to the first treatment.
Step 6
Ongoing follow-up
The patient continues to be monitored for overall survival and any potential side effects from the treatment.
Regular follow-up appointments are scheduled to ensure the patient's health and to gather data on the long-term effects of the treatment.

Who can join the trial?

11 criteria

Children aged 1-17 and adults aged 18-75 can participate.
Participants must not have severe kidney problems. This means their creatinine levels should not be more than three times the normal level for their age.
Participants must not have severe liver problems. This means their direct bilirubin should not be more than 3 mg/dl, and their SGOT should not be more than 500.
The patient or their guardian must be able to give informed consent, which means they understand the study and agree to participate.
Participants must have a type of leukemia called relapsed or refractory B cell precursor Acute Lymphoblastic Leukemia (BCP-ALL). This means the disease has returned or is not responding to treatment. It is defined by having 5% or more cancerous cells in the bone marrow, or if less than 5%, at least 1% of disease detected by a special test called PCR.
There must be evidence of CD19 tumor expression in the bone marrow or blood. This is checked using a test called flow cytometry.
Participants should not have a condition called acute Graft Versus Host Disease (aGVHD) greater than Grade I or chronic GVHD greater than mild in the last 30 days. GVHD is a condition that can occur after a transplant.
Participants should not be taking medications that suppress the immune system for at least 30 days before the treatment.
Participants should not have any life-threatening infections at the time of joining the study.
Participants should have a life expectancy of more than 60 days.
Participants should have a performance score greater than 60 on the Lansky or Karnofsky scale. These scales measure the ability to perform daily activities.

Who cannot join the trial?

7 criteria

Patients with any other type of cancer besides B cell precursor Acute Lymphoblastic Leukemia cannot participate.
Patients who have had a previous treatment with CARCIK-CD19 cells are not eligible.
Patients with severe heart problems are excluded.
Patients with active infections that are not controlled are not allowed to join.
Pregnant or breastfeeding women cannot participate.
Patients with a history of severe allergic reactions to similar treatments are excluded.
Patients who are unable to follow the study procedures for any reason are not eligible.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
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Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy

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Investigated drugs

CARCIK-CD19 cells are a type of treatment that uses the patient's own immune cells to fight cancer. In this therapy, special cells from the patient's blood are taken and changed in a lab to help them find and attack cancer cells. These modified cells are then put back into the patient's body. The goal is to help the immune system recognize and destroy cancer cells more effectively. This treatment is being tested to see if it can help patients with a type of blood cancer called B cell precursor acute lymphoblastic leukemia (BCP-ALL) who have not responded to other treatments or whose cancer has returned.

Carcik-Cd19 Cells

What is already known about the treatment

CARCIK-CD19 – This medication is administered through an infusion, which means it is given directly into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating B cell precursor Acute Lymphoblastic Leukemia, a type of cancer affecting blood and bone marrow. The main goal of using CARCIK-CD19 is to help the immune system target and destroy cancer cells. At the molecular level, it works by using specially modified immune cells that can recognize and attack cancer cells. This medication falls under the category of immunotherapy, which is a type of treatment that uses the body's own immune system to fight cancer.

Investigated diseases

B cell precursor 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 begins in the bone marrow, where these abnormal cells multiply rapidly and crowd out healthy cells. As the disease progresses, these lymphoblasts can spread to other parts of the body, including the lymph nodes, liver, and spleen. The accumulation of these cells can lead to symptoms such as fatigue, fever, and increased risk of infections. Over time, the body's ability to produce normal blood cells is compromised, leading to anemia and bleeding issues. The disease primarily affects children but can also occur in adults.