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Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

Verified siteRegistered drugNo 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 is focused on studying a type of cancer called Indolent Non-Hodgkin Lymphoma, which includes subtypes like Follicular Lymphoma and Marginal Zone Lymphoma. The study is testing a treatment called Axicabtagene Ciloleucel, also known by its code name KTE-C19. This treatment is a form of cell therapy, which involves using a patient's own immune cells that are modified to better fight cancer cells. The purpose of the study is to evaluate how effective this treatment is for patients whose lymphoma has returned or has not responded to previous treatments.

Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor the participants over a period of time to see how their cancer responds to the treatment. This includes checking the levels of the modified immune cells in the blood and observing any changes in the cancer. The study will also look at the safety of the treatment by tracking any side effects that participants may experience.

In addition to Axicabtagene Ciloleucel, the study may involve other medications to support the treatment process. These include Tocilizumab, Dexamethasone, Fludarabine, Cyclophosphamide, Methylprednisolone, Diphenhydramine, Mesna, and Paracetamol. Some of these medications help manage side effects or enhance the effectiveness of the main treatment. The study aims to provide valuable information on how well this new treatment works and its potential benefits for patients with these types of lymphoma.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and health status.

    A negative pregnancy test is required for females of childbearing potential.

  2. Step 2

    Leukapheresis

    A procedure called leukapheresis is performed to collect white blood cells. This is necessary for the preparation of the personalized treatment.

  3. Step 3

    Pre-treatment

    Before receiving the main treatment, medications such as fludarabine and cyclophosphamide are administered intravenously to prepare the body. These are given over a few days.

  4. Step 4

    Treatment with axicabtagene ciloleucel

    The main treatment involves an infusion of axicabtagene ciloleucel, a type of therapy designed to target specific cells in the body.

  5. Step 5

    Post-treatment monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes blood tests and other evaluations at specified intervals such as Day 7, Week 2, and Month 3.

    Monitoring continues periodically for up to 15 years to track long-term outcomes and any side effects.

  6. Step 6

    Follow-up

    Long-term follow-up involves regular check-ups to evaluate overall health and any ongoing effects of the treatment.

Who can join the trial?

8 criteria

  • Must be **18 years or older**.
  • Must have **follicular lymphoma** or **marginal zone lymphoma** that has worsened after at least two treatments with a combination of chemotherapy and immune therapy (like R-bendamustine or R-CHOP).
  • Must have a **measurable disease**, meaning the disease can be measured or seen on a scan.
  • Must not have any known history or presence of lymphoma in the **central nervous system (CNS)**, which includes the brain and spinal cord.
  • If currently on certain therapies, must be able to stop conventional therapy 2 weeks or 5 half-lives (whichever is shorter) or immune checkpoint therapy 3 half-lives before planned **leukapheresis** (a procedure to collect white blood cells).
  • Must have an **ECOG performance status** of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work, and must have adequate kidney, liver, lung, and heart function.
  • Must not be pregnant or breastfeeding (for females) and must agree to use birth control from the time of consent through 12 months after receiving **CAR T cell infusion** (applies to both males and females).
  • Females who can have children must have a negative pregnancy test. Females who have had surgical sterilization or have been postmenopausal for at least 2 years are not considered able to have children.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not the specific types being studied, such as **Follicular Lymphoma**, **Marginal Zone Lymphoma**, or **Indolent Non-Hodgkin Lymphoma**.
  • Patients who have not experienced a return or worsening of their lymphoma after treatment, known as **relapsed** or **refractory** lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to provide informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with certain medical conditions that might interfere with the study treatment or outcomes.
  • Patients who have participated in another clinical trial recently.
  • Patients who have received certain treatments or medications that could affect the study results.
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Investigated drugs

Axicabtagene Ciloleucel is a type of therapy used in this clinical trial. It is a form of treatment known as CAR T-cell therapy. This therapy involves taking a patient's own immune cells, modifying them in a laboratory to better recognize and attack cancer cells, and then infusing them back into the patient. The goal of this treatment is to help the immune system target and destroy cancer cells in patients with relapsed or refractory B-cell indolent non-Hodgkin lymphoma, a type of blood cancer.

What is already known about the treatment

Axicabtagene Ciloleucel – This medication is administered through an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating certain types of non-Hodgkin lymphoma, specifically follicular lymphoma, marginal zone lymphoma, and indolent non-Hodgkin lymphoma. The main therapeutic indication is for patients with relapsed or refractory B-cell indolent non-Hodgkin lymphoma. At the molecular level, axicabtagene ciloleucel works by modifying a patient's own T-cells to recognize and attack cancer cells. It is classified as a CAR T-cell therapy, which is a type of immunotherapy.

Investigated diseases

  • Follicular Lymphoma

    This is a type of non-Hodgkin lymphoma that typically grows slowly and affects the lymphatic system. It originates from B-lymphocytes, a type of white blood cell, and often presents with painless swelling of lymph nodes. Over time, it may spread to other parts of the body, including the bone marrow and spleen. The disease is characterized by periods of remission and relapse, where symptoms may improve and then return. It is considered an indolent form of lymphoma, meaning it progresses at a slower rate compared to more aggressive types.

  • Marginal Zone Lymphoma

    This is a group of slow-growing B-cell non-Hodgkin lymphomas that originate from the marginal zone of lymphoid tissue. It can occur in various parts of the body, including the spleen, lymph nodes, and mucosal tissues. The disease often presents with symptoms such as swollen lymph nodes, fatigue, and sometimes abdominal discomfort. It progresses slowly and may remain stable for long periods before requiring treatment. Marginal zone lymphoma is known for its indolent nature, meaning it typically advances at a gradual pace.

  • Indolent Non-Hodgkin Lymphoma

    This term refers to a category of non-Hodgkin lymphomas that are generally slow-growing and less aggressive. These lymphomas often present with minimal symptoms, such as painless lymph node enlargement, and may not require immediate treatment. Over time, they can spread to other parts of the body, including the bone marrow and spleen. The disease is characterized by a pattern of remission and relapse, where symptoms may improve and then return. Indolent non-Hodgkin lymphomas are known for their prolonged course and gradual progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505169-10-00Protocol codeKTE-C19-105Estimated enrolment158 patientsSponsorKite Pharma Inc.

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