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Study on PTG-CARCIK-CD19 for Adults and Children with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

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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 two types of blood cancers: B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. These are conditions where the body produces abnormal B-cells, a type of white blood cell, which can lead to various health issues. The treatment being tested in this study is called PTG-CARCIK-CD19. This is a type of cell therapy where special cells, known as T-cells, are modified to better recognize and attack cancer cells. The treatment is given as an injection into the bloodstream.

The purpose of the study is to determine the safety and effectiveness of this new treatment in both adults and children who have these types of blood cancers and have not responded to other treatments. Participants will receive the PTG-CARCIK-CD19 treatment and will be monitored to see how well the treatment works and how long the modified cells stay active in the body. Some participants may receive a placebo, which is a substance with no active treatment, to compare the effects.

The study will take place over several years, with regular check-ups to monitor the participants' health and response to the treatment. The goal is to find out if this new approach can help improve the overall response rate, which means how well the cancer responds to the treatment, in patients with these challenging conditions. Participants will be closely observed for any side effects or changes in their condition throughout the study period.

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 a review of medical history and current health status.
Eligibility criteria include having a type of B-cell cancer that has not responded to at least two previous treatments and having a suitable family member who can donate blood cells.
Step 2
Preparation for treatment
Preparation involves obtaining blood cells from a family member who is at least partially matched genetically. These cells are modified in a laboratory to target cancer cells.
The modified cells are called CARCIK-CD19 cells, designed to recognize and attack specific cancer cells.
Step 3
Treatment administration
The treatment is administered through an intravenous infusion, which means the modified cells are delivered directly into the bloodstream.
This process is monitored closely to ensure safety and effectiveness.
Step 4
Monitoring and follow-up
After the infusion, monitoring occurs to assess the body's response to the treatment. This includes regular check-ups and tests to track the presence and activity of the CARCIK-CD19 cells.
The primary goal is to evaluate the treatment's effectiveness and any side effects. This phase lasts for several months, with key assessments at 28 days and 3 months post-infusion.
Step 5
Long-term evaluation
Long-term evaluation continues to monitor the treatment's impact on cancer and overall health. This includes checking for any adverse effects and the persistence of the modified cells in the body.
The study is expected to conclude in September 2027, with ongoing assessments throughout this period.

Who can join the trial?

8 criteria

The patient must be able and willing to provide written consent and follow the study rules.
The patient must not be eligible for commercially available CAR-T cell treatments.
The patient must be a child (1-17 years old) or an adult (18 years or older).
The patient must have a family member who is at least a half-match for certain genetic markers and is willing and eligible to donate blood.
The patient must have a confirmed diagnosis of certain types of B-cell cancers, such as Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia.
The patient must have had a return of cancer or not responded to at least two previous treatments, with no other treatment options expected to help, or the patient must refuse such treatments.
The patient must have at least one measurable area of cancer, as determined by a CT scan, or have cancer in the bone marrow or spleen.
The patient must have a certain level of physical ability, as measured by a performance status scale, which is a way to assess how well a patient can perform daily activities.

Who cannot join the trial?

3 criteria

Patients with medical conditions other than B-Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia cannot participate.
Patients who are not within the specified age ranges cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
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Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy

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Investigated drugs

CARCIK-CD19 is a type of cell therapy used in this clinical trial. It involves using specially modified immune cells called CIK cells, which are taken from a donor. These cells are then engineered to express a chimeric antigen receptor (CAR) that targets CD19, a protein found on the surface of certain cancer cells. The goal of this therapy is to help the immune system recognize and attack cancer cells in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma and B-cell Chronic Lymphocytic Leukemia.

Ptg-Carcik-Cd19

What is already known about the treatment

CARCIK-CD19 – This medication is administered through an infusion of genetically modified immune cells, specifically designed to target cancer cells. It is currently being studied in clinical trials for its effectiveness and safety in treating B-cell Non-Hodgkin Lymphoma and B-cell Chronic Lymphocytic Leukemia. The main therapeutic indication is for patients with relapsed or refractory forms of these cancers. At the molecular level, CARCIK-CD19 works by using a chimeric antigen receptor (CAR) to recognize and attack CD19 proteins on the surface of cancer cells. It falls under the pharmacological classification of cell-based immunotherapy.

Investigated diseases

Non-Hodgkin Lymphoma
This is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. The disease can start in lymph nodes, spleen, or other lymphatic tissues and may spread to other organs. Non-Hodgkin Lymphoma can vary greatly in its progression, with some forms growing slowly and others more aggressively. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The exact cause is often unknown, but it involves genetic mutations in the lymphocytes.
Chronic Lymphocytic Leukemia
This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal lymphocytes. It typically progresses slowly and is most common in older adults. The disease may not cause symptoms initially, but as it advances, it can lead to fatigue, swollen lymph nodes, and frequent infections. Over time, the abnormal cells can crowd out healthy blood cells, leading to anemia and other complications. The cause of Chronic Lymphocytic Leukemia is not fully understood, but it involves genetic changes in the lymphocytes.