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PET Imaging Study for Large B-Cell Lymphoma Patients Using 89Zr-CED88004S Before and After CAR T-Cell Therapy

Verified siteInvestigationalNo 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 focuses on patients with large B-cell lymphoma, a type of cancer that affects the lymphatic system. The study involves a special imaging technique called PET imaging to observe the behavior of certain immune cells, known as CD8+ T-cells, before and after a treatment called CAR T-cell therapy. The treatment uses a tracer called ZED88082A/CED88004S, which is injected into the body to help visualize these immune cells during the imaging process.

The purpose of the study is to understand how CD8+ T-cells are distributed in the body and how they interact with the cancer both before and after the CAR T-cell therapy. This is done by using the PET imaging technique to capture images of the body and analyze the presence and activity of these immune cells. The study aims to see how the distribution of these cells might relate to the effectiveness of the CAR T-cell therapy in treating the lymphoma.

Participants in the study will receive the tracer injection and undergo PET imaging at different stages of their treatment. The study will monitor the uptake of the tracer in both normal tissues and tumor areas to gather information on how the immune cells are behaving. This information could help improve understanding of the treatment process and potentially lead to better outcomes for patients with large B-cell lymphoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of large B-cell lymphoma and ensuring the ability to undergo CAR T-cell therapy.

    A biopsy of the tumor lesion is performed if it can be safely obtained. This is necessary to measure disease according to the Lugano criteria.

  2. Step 2

    Pre-treatment imaging

    Before starting CAR T-cell therapy, a PET scan is conducted using the tracer ZED88082A/CED88004S. This scan helps to visualize the distribution of CD8+ T-cells in the body.

    The tracer is administered through an intravenous injection. The scan is performed two days after the injection to assess the uptake in normal tissues and tumor lesions.

  3. Step 3

    CAR T-cell therapy

    The patient receives CD19-directed CAR T-cell therapy. This therapy involves modifying the patient's own T-cells to better target and attack cancer cells.

    The therapy is administered according to the standard clinical care procedures.

  4. Step 4

    Post-treatment imaging

    After the CAR T-cell therapy, another PET scan is conducted using the same tracer, ZED88082A/CED88004S. This helps to evaluate changes in the distribution of CD8+ T-cells post-therapy.

    The scan is again performed two days after the tracer injection to measure the uptake in the body and tumor lesions.

  5. Step 5

    Safety and response assessment

    Throughout the study, safety assessments are conducted to monitor any adverse effects related to the tracer and the CAR T-cell therapy.

    The response to the therapy is evaluated by correlating the imaging results with the expression of CD8 in tumor biopsies and the persistence of CAR T-cells in the blood.

Who can join the trial?

10 criteria

  • Patients must have a confirmed diagnosis of **Large B-cell lymphoma (LBCL)**, which is a type of cancer that affects the lymphatic system.
  • Female patients who can have children and male patients with partners who can have children must agree to use a very reliable form of **birth control** to prevent pregnancy during the study.
  • Patients must meet the requirements for **anti-CD19 CAR T-cell therapy**, which is a treatment that uses the patient's own immune cells to fight cancer.
  • Patients must have a **tumor lesion** that can be safely biopsied, meaning a small sample of the tumor can be taken for examination.
  • Patients must have a **measurable disease**, which means the cancer can be measured and tracked over time, as defined by the **Lugano criteria**, a set of guidelines for evaluating lymphoma.
  • Patients must sign an **informed consent**, which is a document that explains the study and confirms their willingness to participate.
  • Patients must be **18 years or older** at the time they sign the informed consent.
  • Patients must have a **life expectancy of at least 12 weeks**, meaning they are expected to live for at least 12 more weeks.
  • Patients must have an **ECOG performance status of 0-1**, which is a scale used to assess how well a patient can perform daily activities. A score of 0-1 indicates that the patient is fully active or has some symptoms but can still carry out light work.
  • Patients must be able to **comply with the protocol**, meaning they can follow the study's rules and procedures.

Who cannot join the trial?

4 criteria

  • Patients who do not have Large B-cell lymphoma cannot participate. This is a type of cancer that affects certain white blood cells.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not willing or able to undergo the specific imaging tests required by the study cannot participate. These tests help to see how certain cells are distributed in the body.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • ZED88082A/CED88004S

    is an imaging agent used in this study to visualize and track CD8+ T-cells in patients with large B-cell lymphoma. This agent is used in PET imaging to help researchers see how these immune cells are distributed in the body before and after the patient receives CAR T-cell therapy. The imaging helps to understand how well the therapy is working by showing where the T-cells are located and how they are interacting with the tumor.

  • CD19-directed CAR T-cell therapy

    is a type of treatment that uses the patient's own immune cells, which are modified in the lab to better recognize and attack cancer cells. In this trial, the therapy is specifically designed to target cells that have the CD19 protein on their surface, which is common in certain types of lymphoma. The goal of this therapy is to help the immune system find and destroy cancer cells more effectively.

What is already known about the treatment

ZED88082A/CED88004S – This medication is administered through PET imaging, a type of scan that helps visualize the distribution of certain cells in the body. It is currently being studied in clinical trials for its use in patients with large B-cell lymphoma, particularly in understanding the behavior of CD8+ T-cells before and after CAR T-cell therapy. The main therapeutic indication is to aid in the assessment of immune cell distribution and activity in cancer treatment. At the molecular level, it works by binding to specific markers on T-cells, allowing them to be seen during imaging. It falls under the pharmacological classification of diagnostic radiopharmaceuticals.

Investigated diseases

Large B-cell lymphoma – This is a type of non-Hodgkin lymphoma that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. It is characterized by the rapid growth of large, abnormal B-cells in the lymph nodes, spleen, or other organs. As the disease progresses, it can spread to other parts of the body, including the bone marrow and central nervous system. Symptoms may include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The disease can vary in its rate of progression, with some cases advancing quickly while others develop more slowly. Understanding the distribution and behavior of these cells is crucial for developing effective treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520560-18-00Estimated enrolment27 patientsSponsorUniversitair Medisch Centrum Groningen

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