Not recruitingRare disease

Study of UCART22 for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic 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 B-cell Acute Lymphoblastic Leukemia (B-ALL), specifically in patients whose disease has returned or has not responded to previous treatments. The study is testing a new treatment called UCART22, which involves using specially engineered immune cells known as T-cells. These T-cells are designed to target and attack cancer cells that have a specific marker called CD22 on their surface. The purpose of the study is to evaluate the safety and effectiveness of UCART22 in treating this type of leukemia.

Participants in the study will receive UCART22 through an intravenous infusion, which means the treatment is delivered directly into the bloodstream. The study is divided into two parts: dose-escalation and dose-expansion. In the dose-escalation phase, different doses of UCART22 will be tested to find the safest and most effective dose. In the dose-expansion phase, the selected dose will be given to more patients to confirm its safety and effectiveness. Throughout the study, participants will be closely monitored for any side effects and to see how well the treatment works against the leukemia.

In addition to UCART22, some patients may receive other medications as part of their treatment plan. These include Alemtuzumab (also known as LEMTRADA or CLLS52), Rituximab (known as MabThera), Cyclophosphamide (known as ENDOXAN), and Fludarabine Phosphate (known as Fludara). These medications are used to help prepare the body for the UCART22 treatment and to support the overall treatment process. The study aims to provide valuable information on how UCART22 can be used to treat B-ALL and improve outcomes for patients with this challenging condition.

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
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting physical examinations and laboratory tests to ensure you meet the study criteria.
Step 3
Pre-treatment phase
Before starting the main treatment, you will receive medications to prepare your body. This may include alemtuzumab, rituximab, cyclophosphamide, and fludarabine phosphate. These medications are administered intravenously, which means they are given through a vein. The exact dosage and frequency will be determined by the study team based on your specific needs.
Step 4
Treatment with UCART22
The main treatment involves receiving UCART22, which is a type of engineered T-cell therapy. This is also administered intravenously. The goal is to target and attack specific cancer cells in your body. The dosage will be adjusted during the study to find the most effective and safe amount.
Step 5
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your response to the treatment and to check for any side effects. This includes blood tests, imaging studies, and other assessments as needed. The study team will closely observe your health and make any necessary adjustments to your treatment plan.
Step 6
End of study participation
At the end of your participation in the study, a final assessment will be conducted. This will include a review of your overall health and any changes observed during the trial. You will receive guidance on any further medical care or follow-up needed after the study concludes.

Who can join the trial?

16 criteria

Age:
- Dose Escalation phase: Must be between 15 and 70 years old.
- Dose Expansion phase: Must be between 12 and 70 years old.
- Diagnosis and Prior Therapy: Must have relapsed or refractory B-cell Acute Lymphoblastic Leukemia (R/R B-ALL).
  - Must have received at least one standard chemotherapy treatment and one additional treatment after the first one did not work.
  - There should be no other available treatments that can cure the disease.
  - Must not be eligible for a type of treatment called allogeneic hematopoietic stem cell transplantation (HSCT), or have refused it, or the disease has returned after HSCT, or the disease is too active to allow HSCT at the time of joining the study.
  - For the Dose Expansion phase: Must have received a treatment targeting a protein called CD19.
  - Disease Burden:
    
    Dose Escalation phase: Must have a measurable amount of disease in the bone marrow or outside the central nervous system.
    Dose Expansion phase: Must have at least 5% of disease in the bone marrow.
    CD22 Expression: At least 70% of the leukemia cells must show a protein called CD22.
    Performance Status:
    
    For those 18 years or older: Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
    For those under 18 years: Must have a Lansky/Karnofsky score of 70 or higher, indicating they can care for themselves but may not be able to carry out normal activities or do active work.
    Adequate Organ Function:
    
    Kidney function must be adequate, with a creatinine clearance of at least 60 mL/min.
    Liver enzymes (alanine aminotransferase and aspartate aminotransferase) should not be more than 3 times the normal limit, or 5 times if elevated due to leukemia.
    Total bilirubin should not be more than 2 times the normal limit, or 3 times if elevated due to leukemia.
    Heart function must be adequate, with a left ventricular ejection fraction of at least 50%.
    Women of Childbearing Potential: Must have a negative pregnancy test within 7 days before joining the study.

Who cannot join the trial?

4 criteria

Patients who have not experienced a return or persistence of their B-cell Acute Lymphoblastic Leukemia after treatment.
Patients who have not failed a treatment specifically targeting a protein called CD19.
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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

UCART22 is a type of therapy that uses specially engineered immune cells called T-cells. These T-cells are designed to recognize and attack cancer cells in the body. In this trial, the T-cells are modified to target a specific protein called CD22, which is found on the surface of certain cancer cells in a type of blood cancer known as B-cell Acute Lymphoblastic Leukemia (B-ALL). The goal of this therapy is to help the immune system find and destroy the cancer cells, especially in patients whose cancer has returned or has not responded to previous treatments.

What is already known about the treatment

UCART22 – UCART22 is a medication administered through an infusion, which involves delivering the treatment directly into the bloodstream. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of UCART22 is for treating patients with a type of blood cancer called relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), especially when other treatments have failed. At the molecular level, UCART22 works by using specially engineered T-cells that are designed to target and destroy cancer cells that have a specific marker called CD22 on their surface. This medication falls under the category of immunotherapy, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

B-cell Acute Lymphoblastic Leukemia – B-cell Acute Lymphoblastic Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. These abnormal cells crowd out normal blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses rapidly, with the lymphoblasts multiplying quickly and spreading throughout the body. As the disease advances, it can infiltrate other organs, including the liver, spleen, and central nervous system. The rapid proliferation of these cells can lead to a decrease in the production of healthy blood cells, causing anemia and increasing the risk of infections. The progression of the disease requires prompt medical attention to manage symptoms and prevent further complications.