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Long-Term Follow-Up Study for Patients Treated with Idecabtagene Vicleucel or Lisocabtagene Maraleucel for Cancer

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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 understanding the long-term effects of treatments involving gene-modified T cells. These treatments are used for patients who have previously participated in studies sponsored by Celgene Corporation. The study includes patients who have received at least one infusion of these specially modified cells. The main goal is to assess any delayed side effects that might occur after receiving these treatments. The study will also monitor how long these modified cells remain in the body and check for any potential issues, such as the development of new viruses or changes in the patient's health status over time.

The trial involves two specific treatments: idecabtagene vicleucel and lisocabtagene maraleucel. These are advanced therapies that use a patient's own immune cells, which are modified to better fight certain diseases. The study will follow patients over a long period to ensure their safety and to gather information on the effectiveness of these treatments. This includes looking at any new health conditions that might arise and tracking the overall health and development of younger patients who received the treatment.

Throughout the study, researchers will collect data on various health aspects, such as the presence of the modified cells in the body and any new health issues that could be linked to the treatment. The study aims to provide a comprehensive understanding of the long-term safety and benefits of using **gene-modified T cells** in treating diseases. This information will help improve future treatments and ensure they are safe and effective for patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, it is necessary to sign an informed consent form. This form confirms understanding of the study and agreement to participate.

    For participants under 18, a parent or legal representative must also sign an informed assent form.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline information. This may include a physical examination and review of medical history.

    The purpose is to ensure eligibility and gather data for future comparisons.

  3. Step 3

    Treatment monitoring

    Participants who have previously received genetically modified T cells will be monitored for delayed adverse events. This includes checking for new or worsening conditions.

    Regular follow-up visits are scheduled to assess the long-term effects of the treatment.

  4. Step 4

    Long-term follow-up

    The study involves long-term follow-up to monitor the persistence of genetically modified T cells in the body.

    This includes analysis of the cells and checking for any replication-competent lentiviruses, which are viruses that can reproduce.

  5. Step 5

    Growth and maturity assessment

    For participants under 18 at the time of treatment, assessments of physical growth and sexual maturity are conducted.

    These assessments help understand the impact of the treatment on development.

  6. Step 6

    Safety and efficacy evaluation

    The study evaluates the safety of the treatment by monitoring for any new health issues related to the therapy.

    The efficacy of the treatment is also assessed by tracking disease status, progression, and overall survival.

Who can join the trial?

3 criteria

  • All adult and pediatric subjects who have received at least one infusion of genetically modified (GM) T cells in a previous study sponsored by Celgene or its partners.
  • The subject, or their parent/legal representative if applicable, must understand and voluntarily sign an Informed Consent Form (ICF) or Informed Assent Form (IAF) before any study-related assessments or procedures are conducted. An Informed Consent Form is a document that explains the study and any potential risks, ensuring that participants understand and agree to take part.
  • The subject must be willing and able to follow the study visit schedule and other requirements of the study protocol.

Who cannot join the trial?

1 criterion

  • Patients who have not received at least one infusion of genetically modified T cells in a previous Celgene sponsored study.
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Investigated drugs

Gene-Modified T Cells are a type of therapy where a patient's own immune cells, specifically T cells, are altered in a laboratory to better recognize and attack cancer cells. This process involves collecting T cells from the patient, modifying them to enhance their ability to fight cancer, and then reintroducing them into the patient's body. The goal of this therapy is to improve the body's natural ability to combat cancer by using these enhanced T cells. In this trial, the focus is on understanding the long-term effects and safety of these modified cells, as well as their effectiveness in treating cancer over an extended period.

What is already known about the treatment

Gene-Modified T Cells – This treatment involves the infusion of genetically modified T cells, which are a type of immune cell, into the patient's body. The current status of this therapy in medicine is under investigation, primarily focusing on its long-term safety and effectiveness. It is mainly used for patients who have previously received this treatment in a clinical trial setting, often for conditions that involve the immune system or cancer. At the molecular level, these modified T cells are designed to recognize and attack specific targets, such as cancer cells, by altering their genetic material to enhance their ability to fight disease. This therapy falls under the pharmacological classification of gene therapy, which involves modifying genes to treat or prevent disease.

Investigated diseases

  • Neurologic Disorder

    Neurologic disorders involve the nervous system, which includes the brain, spinal cord, and nerves. These disorders can affect movement, communication, and cognitive functions. Symptoms may develop gradually or suddenly and can include muscle weakness, coordination problems, and changes in sensation. Over time, these disorders may lead to increased difficulty in performing daily activities. The progression can vary widely depending on the specific type of neurologic disorder.

  • Rheumatologic Disorder

    Rheumatologic disorders affect the joints, muscles, and bones, often causing pain, swelling, and stiffness. These conditions can lead to decreased mobility and function over time. Symptoms may fluctuate, with periods of increased activity and remission. As the disorder progresses, it can result in joint damage and deformities. The severity and progression can differ significantly among individuals.

  • Autoimmune Disorder

    Autoimmune disorders occur when the immune system mistakenly attacks the body's own tissues. This can lead to inflammation and damage in various organs and systems. Symptoms often include fatigue, fever, and general malaise, along with specific organ-related symptoms. The progression can be unpredictable, with periods of flare-ups and remission. Over time, chronic inflammation can lead to tissue damage and loss of function.

  • Hematologic Disorder

    Hematologic disorders affect the blood and blood-forming organs, impacting the production and function of blood cells. These disorders can lead to symptoms such as fatigue, weakness, and increased susceptibility to infections. As the condition progresses, it may cause complications like anemia, bleeding disorders, or clotting issues. The progression and impact on health can vary depending on the specific type of hematologic disorder.

  • Infection

    Infections are caused by microorganisms such as bacteria, viruses, fungi, or parasites invading the body. They can lead to symptoms like fever, fatigue, and localized pain or swelling. The progression of an infection depends on the type of microorganism and the body's immune response. Some infections resolve quickly, while others can persist and cause chronic health issues. The severity and duration can vary widely among different infections.

  • Second Primary Malignancy (SPM)

    A second primary malignancy is a new cancer that occurs in an individual who has previously been diagnosed with cancer. This new cancer is distinct from any recurrence or spread of the original cancer. The development of an SPM can be influenced by genetic factors, previous cancer treatments, or environmental exposures. The progression of an SPM depends on the type and location of the new cancer. It requires separate evaluation and management from the initial cancer.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-504201-36-00Protocol codeGC-LTFU-001Estimated enrolment1 410 patientsSponsorCelgene Corp.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).