Not recruitingRare disease

Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma

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 the treatment of certain blood cancers, specifically Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma. These are types of cancers that affect the blood and immune system. The study will use a treatment called DK-CLIC-1901, which involves a special type of cell therapy known as CAR T-cell therapy. This therapy uses a patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The trial will also involve the use of a medication called RoActemra, which contains the active substance tocilizumab. This medication is given as an infusion, meaning it is delivered directly into the bloodstream through a vein.

The purpose of the study is to test the safety and feasibility of using CLIC-1901 CAR T-cell therapy in patients whose cancer has returned or has not responded to previous treatments. Participants in the study will receive the treatment through an intravenous infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor the effects of the treatment over a period of time to understand how well it works and to identify any side effects. The trial will also look at how the treatment affects the overall health and survival of the participants.

Throughout the study, researchers will keep track of various health indicators, such as the response of the cancer to the treatment, any side effects experienced, and the overall survival of the participants. The study aims to provide valuable information on the potential benefits and risks of using CAR T-cell therapy in treating these types of blood cancers. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and organ function.
A signed consent form is required after receiving detailed information about the study.
Step 2
Leukapheresis
A procedure called leukapheresis is performed to collect white blood cells from the blood. This is necessary for the preparation of the CAR T-cells.
Step 3
CAR T-cell preparation
The collected white blood cells are modified in a laboratory to create CLIC-1901 CAR T-cells.
This process may take several weeks.
Step 4
Pre-treatment
Before receiving the CAR T-cells, a short course of chemotherapy may be administered to prepare the body for the infusion.
Step 5
CAR T-cell infusion
The CLIC-1901 CAR T-cells are infused into the bloodstream through an intravenous (IV) line.
This is a one-time procedure.
Step 6
Monitoring and follow-up
After the infusion, close monitoring is conducted to observe the body's response to the treatment.
Regular follow-up visits are scheduled to assess health status and manage any side effects.
Step 7
Treatment of side effects
If side effects such as cytokine release syndrome (CRS) or neurotoxicity occur, treatments like tocilizumab or glucocorticoids may be administered.
Monitoring continues to ensure recovery and manage any complications.

Who can join the trial?

11 criteria

The patient must have a type of blood cancer that has come back or not responded to treatment. This includes certain types of leukemia and lymphoma.
The patient must be between 1 and 70 years old.
The patient should have a life expectancy of at least 12 weeks after joining the study.
The patient must have organs that are working well enough, which includes:
- A score above 50% on a test that measures general health and ability to perform daily activities.
- Lung function tests showing at least 40% of expected performance and oxygen levels above 90% without extra oxygen.
- A heart function test showing more than 45% performance and no signs of heart disease.
- Bilirubin levels (a liver function test) less than 2 times the normal limit for their age, unless they have a specific condition called Gilbert syndrome.
- ALT levels (another liver function test) less than 5 times the normal limit for their age.
- Kidney function tests showing adequate performance.
- The patient must sign a consent form after receiving information about the study.
- The patient must agree to use very effective birth control methods from the time of a specific procedure until at least 12 months after receiving the study treatment. This applies to women who can have children and men with partners who can have children.

Who cannot join the trial?

5 criteria

Patients with certain types of cancer, such as Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma, may not be eligible.
Patients who have not responded to previous treatments or whose cancer has returned might not be able to participate.
Patients who are not within the specified age range for the study may be excluded.
Both male and female patients are considered, but certain conditions may exclude participation.
Patients who are part of a vulnerable population, which means they might need special protection, are not included.

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Verified sites

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Rigshospitalet
Verified
Copenhagen, Denmark

Trial locations

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Investigated drugs

CLIC-1901 CAR T-cell is a type of therapy that uses specially modified cells from the patient's own immune system. These cells are engineered to recognize and attack cancer cells that express a protein called CD19. This therapy is being tested for its safety and feasibility in treating patients with certain types of blood cancers that have not responded to other treatments or have returned after treatment.

What is already known about the treatment

CLIC-1901 CAR T-cell – This medication is administered through an infusion directly into the bloodstream. It is currently being studied in clinical trials for its safety and feasibility in treating relapsed or refractory CD19-expressing hematological malignancies, such as Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma. The main therapeutic indication is for patients whose cancer has returned or is resistant to standard treatments. At the molecular level, CLIC-1901 CAR T-cells are engineered to recognize and attack cancer cells expressing the CD19 protein. This medication falls under the pharmacological classification of cell-based immunotherapy.

Investigated diseases

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 called lymphoblasts. It progresses rapidly, leading to a decrease in the number of healthy blood cells, which can cause symptoms like fatigue, frequent infections, and easy bruising or bleeding. The disease primarily affects children but can also occur in adults. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen.
B-cell Non-Hodgkin Lymphoma
This is a group of blood cancers that originate in the lymphatic system, specifically affecting B-lymphocytes, a type of white blood cell. It can present as either a slow-growing or aggressive form, with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can spread to other organs and tissues, including the bone marrow and spleen. The progression and symptoms can vary widely depending on the specific subtype of B-cell lymphoma.