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Study of TranspoCART19 cell therapy for patients with CD19-positive acute lymphoblastic leukemia that is resistant or refractory to treatment

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 study is looking at a treatment for patients with CD19+ acute lymphoblastic leukemia that has not responded to previous treatments or has come back after treatment. The treatment being tested is called TranspoCART19, which is made from the patient's own blood cells. These cells are collected from the patient's blood and then changed in a laboratory to help them recognize and attack the leukemia cells. The modified cells are designed to find and destroy cells in the body that have a specific marker called CD19 on their surface, which is found on the leukemia cells.

The purpose of this study is to find out the safest dose of TranspoCART19 cells that can be given to patients and to see how well this treatment works in fighting the leukemia. The study is divided into two phases. In the first phase, different doses of the treatment will be tested to determine which dose is safe and can be tolerated by patients. In the second phase, the chosen dose will be used to see how effective it is at treating the leukemia.

During the study, patients will first have some of their blood cells collected through a process where blood is taken from the body, certain cells are separated out, and the remaining blood is returned to the body. These collected cells will then be modified in the laboratory and grown to create the TranspoCART19 treatment. After the treatment is prepared, it will be given back to the patient through an infusion, which means it will be slowly put into the bloodstream through a vein. Patients will be closely watched for any side effects and to see how well the treatment is working against the leukemia. Follow-up visits will continue for up to one year after receiving the treatment to monitor the patient's condition and response to the therapy.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and enrollment
Your medical team will confirm that you have CD19+ acute lymphoblastic leukemia, which is a type of blood cancer affecting white blood cells that has not responded to previous treatments or has returned after treatment.
Tests will be performed to detect measurable disease in your bone marrow or blood using a technique called flow cytometry, which counts and examines cells.
Your general health status will be assessed to ensure you can participate in the trial. This includes checking your ability to perform daily activities and confirming your life expectancy is greater than three months.
Your age must be between 4 and 70 years to be eligible for this trial.
Step 2
Blood collection procedure
You will undergo a procedure called lymphapheresis, which is a process to collect your T cells (a type of white blood cell that fights infections) from your blood.
This procedure requires adequate access to your veins. The medical team will ensure there are no medical reasons preventing you from undergoing this collection.
The collected T cells will be sent to a laboratory for processing and modification.
Step 3
Cell modification and preparation
Your T cells will be genetically modified in the laboratory using a technique called Sleeping Beauty transposons to create TranspoCART19 cells.
These modified cells will be designed to recognize and attack cancer cells that have a protein called CD19 on their surface.
The cells will be expanded (multiplied) in the laboratory to reach the required number for treatment.
This preparation phase occurs outside your body while you may receive other treatments as determined by your medical team.
Step 4
Pre-infusion preparation
Before receiving the TranspoCART19 cells, you may receive preparatory chemotherapy to reduce the number of existing immune cells in your body. This helps the modified cells work more effectively.
The specific medications and timing of this preparation will be determined based on your individual medical condition.
Step 5
TranspoCART19 cell infusion
You will receive the TranspoCART19 cells through an infusion into your vein. This is similar to receiving a blood transfusion.
The dose of cells you receive will be determined based on the phase of the trial and your response. The medical team is working to identify the safest and most effective dose.
The infusion will be given as a cell suspension, which means the cells are mixed in a liquid solution.
Step 6
Immediate monitoring period
After the infusion, you will be closely monitored for any immediate reactions or side effects.
The medical team will watch for signs of cytokine release syndrome, which can occur when the modified cells become active and release substances that cause inflammation in the body.
Monitoring will include checking your vital signs, blood tests, and assessment of any symptoms you experience.
Step 7
Three-month follow-up period
You will have regular medical appointments during the first three months after receiving the TranspoCART19 cells.
Tests will be performed to assess how well the treatment is working, including bone marrow examinations and blood tests to check for cancer cells.
Any side effects or complications will be recorded and graded according to standardized toxicity scales.
Your response to treatment will be evaluated to determine if the cancer is in complete remission (no detectable cancer), partial remission (reduced cancer), or if the disease has progressed.
Step 8
One-year follow-up period
You will continue to have regular follow-up appointments throughout the first year after treatment.
The medical team will monitor for any delayed side effects and assess the long-term effectiveness of the treatment.
Tests will continue to check whether the cancer remains in remission or has returned.
Your overall health status and survival will be tracked during this period.
Step 9
Extended monitoring
Follow-up visits will continue beyond the first year to monitor your long-term health and the durability of the treatment response.
The medical team will assess your progression-free survival, which measures how long you live without the cancer growing or spreading.
Your overall survival and quality of life will continue to be evaluated.
Any late-occurring side effects or complications will be documented and managed appropriately.

Who can join the trial?

7 criteria

You must have a diagnosis of CD19+ acute lymphoblastic leukemia, which is a type of blood cancer affecting white blood cells. Your disease must be in one of these situations: the cancer has come back after treatment or has not responded to treatment, and you are not able to have a transplant either because the disease is not responding or because there is no suitable donor available, or the cancer has returned after you already had a transplant from another person.
You must have measurable disease, meaning that cancer cells can be detected in your bone marrow or blood using a special laboratory test called flow cytometry.
You must be older than 4 years and younger than 70 years.
You must have an ECOG performance status of 0 or 1, which is a scale doctors use to measure how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work. You may also be included with a score of 2 if your limitations are caused by the blood cancer itself.
Your doctors must expect that you will live longer than 3 months.
You must have suitable veins that allow a procedure called lymphapheresis, which is a process to collect certain white blood cells from your blood. You must not have any medical reasons that would prevent this procedure.
You or your legal guardian must sign a document agreeing to participate in the study after being informed about it.

Who cannot join the trial?

1 criterion

The study does not provide specific exclusion criteria in the available information. Please consult with the research team to learn about conditions or situations that might prevent participation in this clinical trial.

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Verified sites

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Hospital Universitario De Navarra
Verified
Pamplona, Spain

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Investigated drugs

TranspoCART19 is an experimental treatment made from the patient's own blood cells called T cells. These T cells are collected from the patient's blood and then modified in a laboratory using a special technique called Sleeping Beauty transposons. The modification teaches these T cells to recognize and attack cancer cells that have a protein called CD19 on their surface. The modified cells also include special parts called 4-1BB and CD3z that help the T cells work better and survive longer in the body, plus a marker called huEGFRt that allows doctors to track the modified cells. Once prepared, these modified T cells are given back to the patient through an infusion to help fight their leukemia.

Transpocart19

What is already known about the treatment

TranspoCART19 – This is an experimental cell therapy currently being studied in clinical trials for patients with a type of blood cancer called acute lymphoblastic leukemia that has not responded to standard treatments. The treatment involves collecting a patient's own immune cells called T cells from their blood, modifying them in the laboratory using a genetic engineering technique called Sleeping Beauty transposon system to recognize and attack cancer cells that have a specific marker called CD19 on their surface, and then infusing these modified cells back into the patient's bloodstream. The modified T cells work by using a specially designed receptor that binds to CD19 on cancer cells and includes additional signaling components (4-1BB and CD3z) that help the T cells survive longer and kill the cancer cells more effectively. This medication belongs to a class of treatments known as CAR-T cell therapies, which are personalized immunotherapies that harness the patient's own immune system to fight cancer.

Investigated diseases

Acute Lymphoblastic Leukemia – Acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow, where blood cells are made. In this disease, the bone marrow produces too many immature white blood cells called lymphoblasts, which do not function properly. These abnormal cells multiply rapidly and crowd out healthy blood cells, including red blood cells, normal white blood cells, and platelets. As the disease progresses, patients may experience weakness, frequent infections, easy bruising or bleeding, and bone pain. The leukemia cells can also spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. In refractory or resistant forms, the disease does not respond adequately to standard treatments or returns after initial improvement.