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Study on KTE-X19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Mantle Cell Lymphoma Responding Partially to Ibrutinib

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 Mantle Cell Lymphoma, which is a rare form of non-Hodgkin's lymphoma. The study is specifically looking at cases where the disease has returned or has not responded to previous treatments. The main treatment being tested in this trial is a type of cell therapy known as KTE-X19, which is a form of CAR-T cell therapy. This therapy involves modifying a patient's own immune cells to better recognize and attack cancer cells. The trial also involves the use of Ibrutinib, a medication that helps to slow down or stop the growth of cancer cells, and is used as a part of the treatment process before the cell therapy.

The purpose of the study is to evaluate how effective the KTE-X19 therapy is in treating patients who have shown a partial response to Ibrutinib treatment. During the study, patients will first receive Ibrutinib to manage their condition. If they achieve a partial response, they will then receive the KTE-X19 therapy. This involves an infusion, which is a way of delivering the treatment directly into the bloodstream. The study will monitor patients for a period of time to assess the response to the treatment and any potential side effects.

In addition to KTE-X19 and Ibrutinib, the study may also involve other medications such as Cyclophosphamide and Fludarabine, which are chemotherapy agents used to prepare the body for the cell therapy. The trial aims to provide insights into the effectiveness of this combination of treatments in managing Mantle Cell Lymphoma and improving patient outcomes. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatment's impact on their condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the study, you will continue taking ibrutinib as a single agent therapy. This medication is taken orally in the form of 140 mg hard capsules. The dosage and frequency will be determined by your healthcare provider based on your specific condition.

    You will be monitored to ensure that you are achieving a partial response to the treatment. This monitoring will involve regular imaging tests such as PET/CT or MRI to assess the status of your disease.

  2. Step 2

    Preparation for CAR-T cell therapy

    If you achieve a partial response with ibrutinib, you will be prepared for the next phase of the study, which involves CAR-T cell therapy. This preparation includes a process called lymphodepletion chemotherapy.

    You will receive two medications: cyclophosphamide and fludarabine. These are administered through infusion. The specific dosage and schedule will be provided by your healthcare team.

  3. Step 3

    CAR-T cell therapy

    After completing the lymphodepletion chemotherapy, you will receive the CAR-T cell therapy, known as KTE-X19. This is administered as an infusion.

    The goal of this therapy is to help your immune system target and destroy cancer cells. You will be closely monitored for any side effects or reactions during and after the infusion.

  4. Step 4

    Follow-up and monitoring

    Following the CAR-T cell therapy, you will have regular follow-up appointments to monitor your response to the treatment. This includes assessing the complete response rate at 90 days after the infusion.

    Additional follow-up will occur at 180 days and 365 days to evaluate the long-term effectiveness and safety of the treatment. Your healthcare team will provide guidance on the schedule and nature of these follow-up visits.

Who can join the trial?

18 criteria

  • Must have signed the Informed Consent Forms (ICF), which means you agree to participate in the study after understanding all the details.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment. Women who cannot have children due to menopause or surgery do not need this test.
  • Women who can have children should avoid getting pregnant by using a highly effective birth control method or not having sexual activity from the time they agree to participate until 12 months after receiving certain treatments.
  • Men who can have children, even if they have had a vasectomy, should use effective birth control and are recommended to use a barrier method or not have sexual activity from the time they agree to participate until 12 months after receiving certain treatments.
  • Must be able to attend treatment sessions and follow-up appointments and be willing and able to follow the study requirements.
  • Must have available previous medical records or samples.
  • Must have a life expectancy of at least 12 weeks.
  • Must be between 18 and 75 years old.
  • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Must have a confirmed diagnosis of mantle-cell lymphoma according to the 2016 WHO classification.
  • Must have relapsed or refractory disease after at least one previous treatment before starting Ibrutinib, including specific drugs like anthracyclines or bendamustine with Rituximab.
  • Must currently be receiving Ibrutinib at the time of joining the study, without any issues tolerating the drug.
  • Must have a confirmed and measurable PR disease status (partial response) through imaging tests like PET/CT or MRI after at least 6 months of Ibrutinib treatment.
  • Must have certain blood test results: Lymphocyte counts of at least 0.1 x 10^9/L, Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L without growth factor support for 7 days (14 days if using pegfilgrastim), Hemoglobin (Hb) of at least 8 g/dL without transfusion for 7 days, and Platelets (PLT) of at least 75 x 10^9/L or 30 x 10^9/L if there is significant bone marrow involvement, without transfusion for 7 days.
  • Must have adequate organ function, including:
    • Adequate liver function: AST/SGOT and ALT/SGPT levels no more than 2.5 times the upper limit of normal (ULN); total bilirubin no more than 1.5 times ULN, except in cases of Gilbert’s syndrome, then no more than 3.0 times ULN.
    • Adequate kidney function: estimated serum creatinine clearance of at least 60 mL/min.
    • Adequate heart function: ejection fraction of at least 50%.
    • Adequate lung function: oxygen saturation (SO2) greater than 92% at rest and no fluid in the lungs.

Who cannot join the trial?

6 criteria

  • Patients who have not experienced a return or worsening of their Mantle-Cell Lymphoma.
  • Patients who are not currently receiving Ibrutinib as a single therapy.
  • Patients who are not in partial remission (PR) during Ibrutinib therapy. Partial remission means the cancer has decreased in size or extent but has not completely disappeared.
  • Patients who are not able to receive the KTE-X19 infusion.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • KTE-X19

    is a type of therapy that uses your own immune cells to fight cancer. These cells are taken from your body, changed in a lab to better attack cancer cells, and then put back into your body. This therapy is specifically designed to target and destroy cancer cells in people with a type of cancer called Mantle-Cell Lymphoma, especially when other treatments have not worked well.

  • Ibrutinib

    is a medication that helps to slow down or stop the growth of cancer cells. It works by blocking a protein that cancer cells need to grow. This medication is used to treat certain types of blood cancers, including Mantle-Cell Lymphoma, and is often used when the cancer has returned or has not responded to other treatments. In this trial, it is used to help patients achieve a partial response before they receive the KTE-X19 therapy.

What is already known about the treatment

KTE-X19 – KTE-X19 is administered as an infusion, which means it is given directly into the bloodstream through a vein. This medication is currently being studied in clinical trials and is not yet widely available in medical practice. It is primarily being investigated for its potential to treat relapsed or refractory mantle-cell lymphoma, a type of cancer that affects the lymphatic system. KTE-X19 works by using genetically modified immune cells, known as CAR-T cells, to target and destroy cancer cells. It falls under the pharmacological classification of CAR-T cell therapies, which are a type of immunotherapy designed to enhance the body's natural defenses against cancer.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin's lymphoma, which is a cancer that originates in the lymphatic system. It specifically affects B-cells, a type of white blood cell that plays a crucial role in the immune response. The disease is characterized by the overproduction of abnormal B-cells, which accumulate in the lymph nodes, spleen, and other organs. As the disease progresses, it can lead to the enlargement of lymph nodes and the spleen, as well as the infiltration of cancerous cells into the bone marrow. This can result in symptoms such as fatigue, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing rapidly while others progress more slowly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502907-31-00Protocol codePRIMACARTEstimated enrolment20 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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