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Study Comparing ARI-0001 and Axicabtagene Ciloleucel for Patients with Relapsed or Refractory 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 Non-Hodgkin Lymphoma, specifically in patients whose disease has returned or not responded to previous treatments. The study is comparing two different treatments that use a special kind of therapy called CAR T-cell therapy. This therapy involves taking a patient's own immune cells, modifying them in a lab to better fight cancer, and then putting them back into the patient's body. The two treatments being compared are called ARI-0001 and Yescarta (also known as axicabtagene ciloleucel).

The purpose of the study is to see if the new treatment, ARI-0001, is as effective as the existing treatment, Yescarta. Patients in the study will be randomly assigned to receive one of these treatments. The study will monitor how long patients live without their cancer getting worse, as well as the safety and side effects of the treatments. The study will also look at how the treatments affect patients' quality of life and how the modified immune cells behave in the body over time.

Participants will receive their assigned treatment through an infusion, which is a way of delivering medicine directly into the bloodstream. The study will follow patients for several months to gather information on the effectiveness and safety of the treatments. This research aims to improve treatment options for patients with Non-Hodgkin Lymphoma and help doctors understand which therapies work best for different patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    Upon joining the study, the patient will review and sign a document called an informed consent form. This document explains the study's purpose, procedures, risks, and benefits. Signing this form indicates that the patient understands the information and agrees to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and possibly some laboratory tests. The goal is to ensure the patient meets the study's criteria, such as having a specific type of lymphoma and being in a certain health condition.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two groups. One group will receive the investigational point-of-care ARI-0001 CAR T-cells, and the other group will receive the commercial standard-of-care axicabtagene ciloleucel (Axi-cel, Yescarta) CAR T-cells. This process is called randomization and helps ensure the study's results are unbiased.

  4. Step 4

    Pre-treatment preparation

    Before receiving the CAR T-cell therapy, the patient may undergo a procedure called leukapheresis. This involves collecting white blood cells from the patient's blood, which are then modified to become CAR T-cells. The patient may also receive a preparative regimen, which could include medications to help the body accept the CAR T-cells.

  5. Step 5

    CAR T-cell infusion

    The patient will receive the CAR T-cells through an intravenous infusion. This means the cells are delivered directly into the bloodstream through a vein. The infusion is a critical part of the treatment and is monitored closely by healthcare professionals.

  6. Step 6

    Monitoring and follow-up

    After the infusion, the patient will be monitored for any side effects or reactions. Regular follow-up visits will be scheduled to assess the patient's response to the treatment and overall health. These visits may include physical exams, blood tests, and imaging studies.

  7. Step 7

    Long-term follow-up

    The patient will continue to be monitored for an extended period, which may last up to 24 months after the infusion. This long-term follow-up helps gather information on the treatment's effectiveness and any lasting effects on the patient's health.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or related subtypes, as defined by the World Health Organization (WHO) 2016 classification. This includes:
    • DLBCL not otherwise specified (NOS)
    • High-grade B-cell lymphoma with specific genetic changes (MYC and BCL2 and/or BCL6 rearrangements) with DLBCL histology
    • FL3B
    • T-cell/histiocyte-rich B-cell lymphoma
    • Primary mediastinal B-cell lymphoma
    • Transformed lymphoma (transformed follicular)
    • Must have experienced a return or worsening of the disease (relapsed/refractory) after at least two different treatments.
    • Must be 18 years of age or older.
    • Must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
    • Can have involvement of the central nervous system (CNS) as long as there are no symptoms that would interfere with assessing neurological side effects.
    • Must have an estimated life expectancy of more than 3 months, excluding the primary disease.
    • If capable of having children, must agree to use birth control from the time of joining the study and for four months after receiving the treatment.
    • Must provide signed and dated informed consent before any trial-specific procedures are conducted.
    • Must be capable of understanding and giving informed consent.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Non-Hodgkin Lymphoma cannot participate.
  • Patients who have not experienced a return or worsening of their Non-Hodgkin Lymphoma after treatment cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to understand or follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
  • Patients who have an active infection that requires treatment cannot participate.
  • Patients who have a history of severe allergic reactions to similar treatments cannot participate.
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Investigated drugs

  • ARI-0001 CAR T-cells

    are a type of therapy where a patient's own immune cells, called T-cells, are taken from their blood and modified in a laboratory to better recognize and attack cancer cells. These modified cells are then returned to the patient's body to help fight the cancer. In this trial, ARI-0001 CAR T-cells are produced at the point of care, meaning they are prepared and administered at the same location where the patient is being treated.

  • Axicabtagene Ciloleucel (Axi-cel, Yescarta)

    is a commercial CAR T-cell therapy. Similar to ARI-0001, it involves modifying a patient's T-cells to target and destroy cancer cells. However, Axi-cel is produced by a pharmaceutical company and is a standard treatment option for certain types of lymphoma. In this trial, it serves as the standard-of-care treatment against which the new ARI-0001 CAR T-cells are being compared.

What is already known about the treatment

  • ARI-0001 CAR T-cells

    This medication is administered through an infusion, where specially modified T-cells are introduced into the patient's bloodstream. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory Non-Hodgkin Lymphoma. The main therapeutic use is to help the immune system target and destroy cancer cells. At the molecular level, these CAR T-cells are engineered to recognize and bind to specific proteins on the surface of cancer cells, leading to their destruction. It falls under the pharmacological classification of cell-based immunotherapy.

  • Axicabtagene Ciloleucel (Yescarta)

    This medication is also given via infusion, where genetically modified T-cells are infused into the patient to fight cancer. It is an approved treatment for certain types of Non-Hodgkin Lymphoma, particularly when the disease has returned or not responded to other treatments. The main therapeutic indication is to enhance the body's immune response against cancer cells. On a molecular level, these CAR T-cells are designed to attach to specific proteins on cancer cells, triggering their elimination. It is classified as a type of cell-based immunotherapy.

Investigated diseases

Non-Hodgkin Lymphoma – Non-Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. The disease can start in lymph nodes, but it can also affect other organs. As it progresses, it may spread to other parts of the lymphatic system and beyond. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary significantly depending on the specific subtype and other factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511979-15-00Protocol codeHO161Estimated enrolment340 patientsSponsorUniversitair Medisch Centrum Groningen

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