Not recruitingRare disease

Study on the Safety and Effectiveness of AUTO1 for Adults with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Using a Drug Combination

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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 or refractory B cell acute lymphoblastic leukemia. This condition occurs when the cancer returns or does not respond to treatment. The study is testing a new treatment called AUTO1, which is a special kind of therapy that uses the patient's own immune cells, known as T cells. These T cells are modified in a laboratory to better recognize and attack cancer cells. The purpose of the study is to evaluate the safety and effectiveness of this treatment.

Participants in the study will receive the AUTO1 treatment through an infusion, which means it is given directly into the bloodstream. The study will monitor how well the treatment works and any side effects that may occur. The trial will also compare the results with those of other treatments, such as Paracetamol, Fludarabine, and Cyclophosphamide, which are used for different purposes in cancer treatment. Some participants may receive a placebo, which is a substance with no active medication, to help understand the effects of the new treatment.

The study will take place over several months, and participants will have regular check-ups to assess their health and the progress of the treatment. The goal is to find out if AUTO1 can help patients with this type of leukemia and to ensure it is safe for use. This research is important for developing new and effective treatments for people with this challenging condition.

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 age, health status, and specific medical conditions related to B cell acute lymphoblastic leukaemia.
Eligibility criteria include being 18 years or older, having a specific performance status, and confirming CD19-positive B-ALL. Additional criteria apply for patients with Philadelphia chromosome positive ALL.
Step 2
Pre-treatment phase
Before receiving the main treatment, certain medications are administered. These include paracetamol in tablet form and fludarabine phosphate as an injection or infusion.
The purpose of these medications is to prepare the body for the main treatment and manage any potential side effects.
Step 3
Main treatment
The main treatment involves the administration of AUTO1, a type of CAR T cell therapy. This is given through an intravenous infusion.
The goal of this treatment is to target and eliminate cancer cells by using modified T cells that specifically attack CD19-positive cells.
Step 4
Post-treatment monitoring
After the infusion of AUTO1, close monitoring is required to assess the treatment's safety and effectiveness.
This includes regular check-ups to track any adverse events and to measure the presence of CAR T cells in the blood.
Step 5
Follow-up assessments
Follow-up assessments are conducted to evaluate the overall response to the treatment. This includes checking for complete remission and monitoring for any remaining cancer cells.
The duration of remission and overall survival rates are also assessed during this phase.

Who can join the trial?

6 criteria

Must be 18 years or older.
Must have an ECOG performance status of 0 or 1. This means the person is fully active or has some symptoms but can still do light work.
Must have relapsed or refractory CD19-positive B-ALL. This means the type of leukemia has come back or is not responding to treatment.
Patients with Philadelphia chromosome positive ALL (Ph+ ALL) can join if they cannot tolerate or have not responded to two types of a specific medicine called tyrosine kinase inhibitor (TKI), or one type of a newer TKI, or if they cannot take TKI for medical reasons.
If treated with a medicine called blinatumomab, the presence of CD19 must be confirmed after stopping this treatment.
Must have adequate function of the kidneys, liver, lungs, and heart. This means these organs are working well enough.

Who cannot join the trial?

4 criteria

Patients with certain types of cancer that have come back or do not respond to treatment, specifically **B cell acute lymphoblastic leukaemia**.
Patients who are not within the age range specified for the study.
Patients who do not meet the gender requirements for the study.
Patients who are considered 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

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Hospital Universitario Y Politecnico La Fe
Valencia, Spain
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Hospital Vall d’Hebron
Barcelona, Spain
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Virgen del Rocío University Hospital
Sevilla, Spain

Trial locations

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Investigated drugs

AUTO1 is a CAR T cell treatment designed to target a specific protein called CD19 found on the surface of certain cancer cells. This therapy involves modifying a patient's own T cells, a type of immune cell, to better recognize and attack cancer cells. AUTO1 is being studied for its safety and effectiveness in treating adult patients with a type of blood cancer known as relapsed or refractory B cell acute lymphoblastic leukemia.

What is already known about the treatment

AUTO1 – AUTO1 is a CAR T cell therapy administered through infusion, specifically designed for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. Currently, it is being evaluated in clinical trials to assess its safety and effectiveness. The main therapeutic indication for AUTO1 is to treat this specific type of leukemia. At the molecular level, AUTO1 works by modifying a patient's T cells to target and destroy cancer cells expressing the CD19 protein. It falls under the pharmacological classification of immunotherapy, specifically CAR T cell therapy.

Investigated diseases

Relapsed or refractory 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 is termed "relapsed" when the disease returns after treatment and "refractory" when it does not respond to treatment. The disease progresses as these abnormal cells multiply rapidly, crowding out normal cells and leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. As the condition advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The accumulation of these cancerous cells disrupts normal blood cell production, leading to anemia and other complications.