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Infusion Study of ARI-0001 Cells for Patients with Resistant or Refractory CD19+ Acute Lymphoid Leukemia

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 a type of blood cancer called acute lymphoid leukemia, specifically in patients whose disease is resistant or does not respond to standard treatments. The main treatment being tested in this study is called Varnimcabtagene autoleucel, also known by its code name ARI-0001. This treatment involves using a patient's own immune cells, which are collected, modified in a laboratory to better fight cancer, and then infused back into the patient. The study aims to evaluate how effective this treatment is in helping patients with this type of leukemia.

In addition to ARI-0001, other medications may be used during the study, including Bendamustine, Fludarabine, Cyclophosphamide, Tocilizumab, Dexchlorpheniramine, Paracetamol, and Allopurinol. These medications serve various purposes, such as chemotherapy, managing side effects, or supporting the patient's overall health during the trial. The study will also include a placebo group to compare the effects of the treatment.

Participants in the study will receive the ARI-0001 treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will monitor patients over a period to assess the response to the treatment, the duration of the response, and any side effects that may occur. The goal is to determine if ARI-0001 can effectively treat acute lymphoid leukemia and improve patient outcomes. The study will also track the survival of the modified cells in the body and any potential adverse effects related to the treatment.

The research process

The trial runs in 7 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 CD19+ acute lymphoid leukemia and ensuring the patient meets specific criteria such as age and health status.
Step 2
Lymphapheresis procedure
A procedure called lymphapheresis is performed to collect T-cells from the patient's blood. These cells are essential for creating the ARI-0001 cells used in the study.
Step 3
Pre-treatment medication
Before the infusion of ARI-0001 cells, medications are administered to prepare the body. This includes bendamustine and fludarabine given through intravenous infusion, and allopurinol taken orally.
Step 4
Infusion of ARI-0001 cells
The patient receives an infusion of ARI-0001 cells, which are T-cells modified to target leukemia cells. This is done through an intravenous infusion.
Step 5
Post-infusion monitoring
After the infusion, the patient is closely monitored for any side effects or reactions. Medications such as tocilizumab and paracetamol may be administered to manage symptoms.
Step 6
Follow-up assessments
Regular follow-up assessments are conducted to evaluate the response to treatment. This includes checking for the presence of leukemia cells and monitoring the survival of ARI-0001 cells in the body.
Step 7
Long-term monitoring
The patient undergoes long-term monitoring to assess the duration of response and overall survival. This involves periodic evaluations over a span of up to two years.

Who can join the trial?

8 criteria

The patient must have a diagnosis of CD19+ acute lymphoid leukemia. This is a type of blood cancer that affects certain white blood cells.
The patient should have a life expectancy of less than 2 years and meet specific conditions, such as having the disease return or not responding to treatment, and not being a candidate for a transplant.
The disease must be measurable, meaning it can be detected in the bone marrow or blood using a test called flow cytometry.
The patient must be between 18 and 70 years old.
The patient should have an ECOG functional status of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
The patient must have a life expectancy of at least 3 months.
The patient needs to have suitable veins for a procedure called lymphapheresis, which involves collecting certain blood cells. There should be no medical reasons preventing this procedure.
The patient must sign an informed consent form, which means they agree to participate in the study after understanding all the details and risks.

Who cannot join the trial?

4 criteria

Patients who have a different type of leukemia or cancer that is not acute lymphoid leukemia.
Patients who are not resistant or refractory to current treatments. Resistant means the disease does not respond to treatment, and refractory means the disease returns after treatment.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
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Barcelona, Spain
Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain
Hospital General Universitario Gregorio Maranon
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Madrid, Spain

Trial locations

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Investigated drugs

ARI-0001 cells: This therapy involves using a patient's own T-cells, which are a type of white blood cell important for the immune system. These T-cells are collected from the patient's blood and then modified in the laboratory. The modification involves expanding the number of T-cells and introducing a new gene using a lentivirus. This gene allows the T-cells to produce a special receptor called a chimeric antigen receptor (CAR) that specifically targets a protein called CD19 found on certain cancer cells. The modified T-cells, now called ARI-0001 cells, are then infused back into the patient. The goal is for these cells to recognize and attack the cancer cells in patients with CD19+ acute lymphoid leukemia that has not responded to other treatments.

What is already known about the treatment

ARI-0001 cells – This medication involves the infusion of specially modified T-cells, which are a type of white blood cell, into the patient's bloodstream. These T-cells are taken from the patient's own blood, expanded in number, and genetically altered using a lentivirus to express a chimeric antigen receptor (CAR) that targets the CD19 protein found on certain leukemia cells. The CAR is designed with additional regions, 4-1BB and CD3z, to enhance the T-cells' ability to attack cancer cells. Currently, ARI-0001 cells are being studied in clinical trials for their effectiveness in treating patients with acute lymphoid leukemia that does not respond to standard treatments. This approach is part of a broader category of cancer immunotherapy, which aims to harness the body's immune system to fight cancer.

Investigated diseases

Acute lymphoid leukemia – Acute lymphoid leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as lymphoblasts. These cells crowd out normal cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses rapidly, requiring prompt medical intervention. It primarily affects children but can also occur in adults. The progression involves the accumulation of these abnormal cells in the blood, bone marrow, and sometimes other organs.