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PET Imaging with 89Zr-Atezolizumab in Patients with Large B-cell Lymphoma Undergoing CD19 CAR T-cell Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). The study involves a treatment known as CD19-directed CAR T-cell therapy, which is a specialized treatment that uses the patient's own immune cells to fight cancer. The trial will use a medication called 89Zr-atezolizumab, which is a form of the drug Tecentriq, to help visualize certain proteins in the body through imaging techniques.

The purpose of the study is to explore how a protein called PD-L1 is expressed in both normal tissues and cancerous areas before patients receive CAR T-cell therapy. This will be done using a special imaging method called PET/CT scan, which combines two types of scans to provide detailed pictures of the inside of the body. The study aims to see if the amount of 89Zr-atezolizumab taken up by the body can help distinguish between active cancer and other treatment-related changes.

Participants in the study will undergo PET/CT imaging before and after receiving CAR T-cell therapy. The study will also look at how the uptake of 89Zr-atezolizumab relates to the effectiveness of the CAR T-cell therapy and any side effects that may occur. This research hopes to provide insights into the role of PD-L1 in DLBCL and improve understanding of how patients respond to CAR T-cell therapy.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of diffuse large B-cell lymphoma and ensuring eligibility for CAR T-cell therapy.
The assessment involves reviewing medical history and conducting necessary tests to confirm measurable disease as per the Lugano criteria.
Step 2
Consent and preparation
Signing informed consent is required to participate in the study. This confirms understanding and agreement to the study procedures.
Preparation for the study includes ensuring the ability to comply with the protocol requirements.
Step 3
PET/CT imaging with 89Zr-atezolizumab
The study involves PET/CT imaging using a tracer called 89Zr-atezolizumab. This imaging helps to study the expression of PD-L1 in normal tissue and lymphoma lesions.
The imaging is conducted before the start of CAR T-cell therapy to measure the uptake of 89Zr-atezolizumab, which is used to assess lymphoma activity and potential treatment-related inflammation.
Step 4
CAR T-cell therapy
Following the imaging, CAR T-cell therapy is administered. This therapy involves using modified T-cells to target and destroy cancer cells.
The response to this therapy is monitored, and the correlation with the initial PET/CT imaging results is studied.
Step 5
Follow-up imaging and assessment
After the CAR T-cell therapy, additional PET/CT imaging may be conducted to assess the treatment's impact and any inflammatory reactions.
The study aims to differentiate between lymphoma activity and treatment-related inflammation using the imaging results.
Step 6
Data analysis and conclusion
The data collected from the imaging and therapy response is analyzed to identify clinically relevant PD-L1 expression.
The study concludes with an evaluation of the correlation between 89Zr-atezolizumab uptake and the effectiveness of CAR T-cell therapy.

Who can join the trial?

6 criteria

The patient must have a confirmed diagnosis of **Diffuse Large B-cell Lymphoma (DLBCL)** or related subtypes. This includes specific types of aggressive B-cell lymphomas as defined by medical guidelines.
The patient must be eligible for **CAR T-cell therapy**. This is a type of treatment that uses the patient's own immune cells to fight cancer, and eligibility is determined by a national medical board.
The patient must have a **measurable disease**. This means that the cancer can be measured or seen on medical imaging tests, according to specific criteria used by doctors.
The patient must have signed an **informed consent** form. This means they understand the study and agree to participate.
The patient must be **18 years or older** at the time they sign the informed consent form.
The patient must be able to **comply with the protocol**. This means they can follow the study's rules and procedures.

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Verified sites

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Universitair Medisch Centrum Groningen
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Groningen, The Netherlands

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Investigated drugs

Atezolizumab
is a medication used in this study to help visualize certain proteins in the body through imaging. It is used in combination with a special type of scan called PET/CT to see how much of the protein PD-L1 is present in both normal tissues and lymphoma lesions. This helps doctors understand how the lymphoma might respond to treatment.
CD19-directed CAR T-cell therapy
is a type of treatment that uses the patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. This therapy specifically targets a protein called CD19 found on the surface of certain cancer cells, including those in large B-cell lymphoma. The goal is to help the immune system fight the cancer more effectively.

Atezolizumab

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously and is currently being studied in clinical trials for its use in imaging and treatment of (Diffuse) Large B-cell Lymphoma. It is a monoclonal antibody that targets the PD-L1 protein, which can help the immune system recognize and attack cancer cells. This medication is classified as an immune checkpoint inhibitor. In this study, it is used in combination with a radioactive tracer, 89Zr, to visualize PD-L1 expression in lymphoma lesions through PET/CT imaging, aiming to predict the response to CD19-directed CAR T-cell therapy.

Investigated diseases

Diffuse Large B-cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can start in any part of the body and may spread to other areas, including the bone marrow and central nervous system. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly. It is the most common type of non-Hodgkin lymphoma in adults.