Study on CART 19/22 T Cells and CART45RA-NKG2D Cells for Treating Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents, and Young Adults

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called acute lymphoblastic leukemia (ALL), which can be difficult to treat when it comes back or does not respond to standard treatments. The study is specifically for children, adolescents, and young adults who have this condition. The trial will explore the use of two different cell therapies: CART 19/22 T cells and CART45RA-NKG2D cells. These treatments involve using special cells that are designed to target and fight the cancer cells in the body. The CART 19/22 T cells are used for a type of ALL that involves certain markers called CD19 and CD22, while the CART45RA-NKG2D cells are used for another type of ALL known as T-ALL.

The purpose of the study is to determine how safe and feasible these treatments are for patients. Participants will receive the treatment through an intravenous infusion, which means the cells are given directly into the bloodstream. The study will monitor the patients to see how their bodies respond to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active treatment, to help compare the effects of the actual treatment.

Throughout the study, researchers will collect samples from the patients, such as blood and bone marrow, to understand how the treatment is working. They will also look at specific markers in the cancer cells and the patients’ immune responses. The trial aims to provide valuable information on whether these new cell therapies can be a safe and effective option for treating relapsed or refractory acute lymphoblastic leukemia in young patients.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of acute lymphoblastic leukemia (ALL).

Written informed consent is required from the patient or their legal representative.

2 pre-treatment assessment

A comprehensive health evaluation is conducted to ensure adequate renal, hepatic, pulmonary, and cardiac function.

Blood tests are performed to check neutrophil, platelet, and lymphocyte counts.

3 lymphoapheresis

A procedure called lymphoapheresis is carried out to collect T cells from the patient’s blood.

This step requires adequate venous access and no contraindications for the procedure.

4 CART cell preparation

The collected T cells are modified in a laboratory to create CART 19/22 T cells or CART45RA-NKG2D cells.

This process involves engineering the cells to target specific proteins on leukemia cells.

5 treatment administration

The modified CART cells are administered to the patient through an intravenous infusion.

The infusion process is monitored closely for any immediate reactions.

6 post-treatment monitoring

Regular follow-up visits are scheduled to monitor the patient’s response to the treatment.

Blood samples are taken to assess the persistence of CART cells and to evaluate the immune response.

7 long-term follow-up

The patient’s health is monitored over an extended period to evaluate the long-term effects and safety of the treatment.

The study is expected to continue until June 2029, with ongoing assessments of treatment outcomes.

Who Can Join the Study?

Patients must be younger than 30 years old at the time of diagnosis or relapse.
Patients must have a Lansky score (for those under 16 years) or Karnofsky score (for those 16 years and older) of 50 or higher. These scores measure the patient’s ability to perform daily activities.
Patients should have a life expectancy of more than 12 weeks.
Patients need an absolute neutrophil count (ANC) of at least 500/μL, unless the low count is due to leukemia and can be improved with treatment. Neutrophils are a type of white blood cell important for fighting infections.
Patients should have a platelet count of at least 50,000/μL, unless the low count is due to leukemia and can be improved with treatment. Platelets help with blood clotting.
Patients must have an absolute lymphocyte count of at least 100/μL. Lymphocytes are a type of white blood cell important for the immune system.
Patients need to have proper kidney, liver, lung, and heart function.
Patients must have good venous access and no reasons preventing them from undergoing lymphoapheresis, a procedure to collect white blood cells.
Patients with a seizure disorder can join if their seizures are well controlled with medication.
The patient or their legal representative, parent(s), or guardian must be able to provide written consent to participate.
For ARM A: Patients must have CD19+/- CD22+ B-ALL that has relapsed or is not responding to standard chemotherapy, with no other cure available. Previous treatment with CART CD19 therapy is allowed but not required.
For ARM B: Patients must have T-ALL that has relapsed or is not responding to standard chemotherapy, with no other cure available.
Patients diagnosed with ALL should be suitable for an allogeneic HSCT (a type of stem cell transplant) and willing to proceed if the CART treatment leads to complete remission and the doctor believes it is the best option.
For ARM B, there must be a suitable haploidentical donor available, which means a donor who is a partial genetic match, following local procedures.

Who Cannot Join the Study?

Where you can join this trial?

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Site Name	City	Country	Status
Fbcxptmsc Pyny Lt Irhvbrfpuzxok Bgchrwiwi Deb Hlqwlgbm Umnwobltmcwhd Lc Pvg	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Cart 19/22 T Cells

CART-19/22 is a type of cell therapy used in this clinical trial. It involves modifying a patient’s own immune cells, called T cells, to better recognize and attack cancer cells. This therapy is specifically designed for patients with a type of leukemia that has returned or is not responding to other treatments. The modified T cells target specific proteins, CD19 and CD22, found on the surface of the cancer cells.

CART-NKG2D T is another cell therapy being tested in the trial. Unlike the first therapy, this one uses T cells from a donor, not the patient. These donor T cells are engineered to target a different protein, NKG2D, which is present on the cancer cells. This therapy is aimed at treating a different type of leukemia that is also resistant to standard treatments.

Acute Lymphoblastic Leukemia (ALL) – 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 progresses rapidly and can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. In children, adolescents, and young adults, it often presents with symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. The disease is classified into subtypes based on the type of lymphocytes affected, either B-cell or T-cell lineage. Refractory or relapsed ALL refers to cases where the disease does not respond to treatment or returns after a period of remission.

Trial ID:

2023-509723-41-01

Protocol code:

REALL_ CART

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on CART 19/22 T Cells and CART45RA-NKG2D Cells for Treating Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents, and Young Adults

What is this study about?

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