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Long-term Follow-up Study for Patients with Solid and Blood Cancers Treated with Brexucabtagene Autoleucel or Axicabtagene Ciloleucel

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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 the long-term follow-up of patients who have been treated with gene-modified cells in previous studies. The diseases being studied include various types of cancer, specifically those affecting blood and solid tissues. The treatments being used in this study are two advanced therapies: Tecartus (also known by its code name KTE-X19) and Yescarta (also known by its code name KTE-C19). Both treatments involve a type of cell therapy where a patient's own T cells, a kind of immune cell, are genetically modified to better recognize and attack cancer cells. These modified cells are then infused back into the patient.

The purpose of this study is to monitor the long-term effects of these gene-modified cell therapies. Researchers are particularly interested in understanding any late-onset side effects that might occur, such as neurological disorders, autoimmune disorders, blood-related disorders, serious infections, and the development of new cancers. The study will also look at how these treatments might affect the growth and development of children and teenagers who have received them. Participants will be followed over a long period to gather this information.

Throughout the study, participants will receive regular check-ups to assess their health and any potential side effects. This includes monitoring for any new symptoms or changes in their condition. The study aims to provide valuable insights into the safety and long-term impact of these innovative cancer treatments, helping to improve future therapies and patient care.

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 that the participant has previously received an infusion of gene-modified cells in a completed Kite-sponsored study and has completed the necessary follow-up assessments in that study.

    The participant must sign an informed consent form, indicating understanding and agreement to participate in the study.

  2. Step 2

    Treatment administration

    Participants who have previously received gene-modified cells, such as brexucabtagene autoleucel or axicabtagene ciloleucel, will continue to be monitored. These treatments are administered as an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein.

  3. Step 3

    Regular follow-up visits

    Participants will attend regular follow-up visits to monitor their health and any potential side effects. These visits are crucial for evaluating the incidence and severity of any late-onset adverse effects, which may include neurological, autoimmune, or hematological disorders, serious infections, or secondary malignancies.

    During these visits, assessments will be made regarding the participant's growth, development, and sexual maturity, particularly for pediatric and adolescent participants.

  4. Step 4

    Monitoring and data collection

    Throughout the study, data will be collected on various health parameters, including the occurrence of any adverse effects, the participant's survival status, and any subsequent anti-cancer therapies received.

    The study aims to understand the mechanisms of any adverse effects related to the gene-modified cell therapy, such as insertional mutagenesis, and to assess immune system recovery.

  5. Step 5

    Study completion

    The study is expected to continue until September 2038. Participants will be monitored throughout this period to gather comprehensive data on the long-term effects of the gene-modified cell therapy.

Who can join the trial?

7 criteria

  • The person must have received an infusion of gene-modified cells in a previous study sponsored by Kite. This means they have been treated with cells that have been changed in a lab to help fight disease.
  • The person must not have withdrawn their full consent or stopped participating in the previous study.
  • The person must have completed the required follow-up checks in the previous study.
  • The person must understand and voluntarily sign an Informed Consent Form or an Informed Assent Form before any study-related checks or procedures are done. This means they agree to participate after being informed about the study.
  • The person must be willing and able to follow the schedule for follow-up visits and meet the study requirements, according to the investigator's judgment.
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

6 criteria

  • Patients with certain types of cancer, specifically solid and hematological malignancies, cannot participate. This means cancers that form solid tumors or affect the blood, bone marrow, or lymph nodes.
  • Patients who have experienced serious side effects related to gene-modified cells, such as neurological disorders (problems with the brain or nerves), autoimmune disorders (conditions where the immune system attacks the body), hematological disorders (issues with blood), serious infections, or secondary malignancies (new cancers that develop after treatment), are excluded.
  • Patients who have conditions related to RCR/RCL (types of viral infections) or insertional mutagenesis (genetic changes caused by the treatment) are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study includes children, adolescents, and adults.
  • Both male and female patients are considered, but those who do not meet other criteria are excluded.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.
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Investigated drugs

Gene-Modified Cells are a type of therapy used in this clinical trial. These cells have been altered in a laboratory to enhance their ability to fight diseases, such as certain types of cancer. The trial aims to monitor the long-term effects of these modified cells on patients, including any potential late-onset side effects or serious health issues that might arise after treatment. The study also looks at how these cells might affect the growth and development of younger patients.

What is already known about the treatment

Gene-Modified Cell Therapy – This therapy is administered through infusion, where modified cells are introduced into the patient's bloodstream. Currently, it is under investigation in clinical trials, particularly for its long-term effects and safety profile. The main therapeutic indications include treating solid and hematological malignancies. At the molecular level, the therapy involves altering the patient's cells to enhance their ability to target and destroy cancer cells. It falls under the pharmacological classification of gene therapy, which aims to modify or manipulate the expression of genes to treat or prevent disease.

Investigated diseases

Solid and Hematological Malignancies – These are types of cancer that can affect various parts of the body. Solid malignancies refer to tumors that form in solid organs or tissues, such as the breast, lung, or prostate. Hematological malignancies involve cancers of the blood, bone marrow, or lymph nodes, such as leukemia, lymphoma, and myeloma. The progression of these diseases can vary widely, with some growing slowly and others rapidly. They may spread to other parts of the body, affecting overall health and organ function. The symptoms and impact depend on the specific type and location of the malignancy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507041-28-00Protocol codeKT-US-982-5968Estimated enrolment504 patientsSponsorKite Pharma Inc.

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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.

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