Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of Lisocabtagene Maraleucel as First Treatment for Adults with Primary Central Nervous System Lymphoma Who Cannot Have a Stem Cell Transplant

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a type of cancer called Primary Central Nervous System Lymphoma, which is a cancer that affects the brain and spinal cord. The main treatment being tested is lisocabtagene maraleucel, also known by its code name BMS-986387/JCAR017. This is a special type of treatment where a patient's own immune cells are collected and modified in a laboratory to help fight the cancer. Other medications that may be used in this study include temozolomide, calcium folinate, methotrexate, procarbazine, fludarabine, cyclophosphamide, tocilizumab, and rituximab. The study is designed for patients who are newly diagnosed with this type of lymphoma and who are not able to have a procedure called autologous stem cell transplant.

The purpose of this study is to find out if lisocabtagene maraleucel can prevent the cancer from getting worse within one year after the treatment is given to patients who have not been able to receive a stem cell transplant. The study will also look at how long it takes for the cancer to get worse, how long patients live after joining the study, how many patients show no signs of cancer after treatment, and how long any improvements last. Additionally, the study will examine how the treatment affects patients' daily lives and what side effects or health problems patients may experience during the study.

During the study, patients will first receive standard treatments to reduce their cancer as much as possible. Before receiving lisocabtagene maraleucel, patients will be given medications to prepare their body for the modified immune cells. The treatment involves collecting the patient's own immune cells, modifying them in a laboratory, and then giving them back to the patient through an injection into a vein. Patients will be closely watched for any health problems and to see how well the treatment works. The study will continue to follow patients for several years to understand the long-term effects of the treatment.

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

    Initial treatment phase with standard therapy

    Before joining this study, your cancer must have been treated with standard therapy containing high-dose methotrexate (HD-MTX). This is a medication given by injection that works to stop cancer cells from growing.

    Your cancer must show signs of being completely gone or mostly gone after this initial treatment before you can proceed to the next steps of the study.

  2. Step 2

    Preparation phase with chemotherapy

    You will receive fludarabine, which is given through a vein (intravenous). This medication helps prepare your body for the main treatment.

    You will also receive cyclophosphamide, which is also given through a vein (intravenous). This medication works together with fludarabine to prepare your immune system.

    These medications are part of a preparation process called lymphodepletion, which reduces the number of certain immune cells in your body to make room for the treatment that follows.

  3. Step 3

    Main treatment with lisocabtagene maraleucel

    You will receive lisocabtagene maraleucel (also called liso-cel). This is the main study treatment and is given as a single dose through a vein (intravenous).

    This treatment is a type of therapy that uses modified cells to help your immune system fight the cancer. It is given as a cell suspension for injection.

    This is a one-time treatment that will be administered after the preparation phase is complete.

  4. Step 4

    Management of potential side effects

    If needed, you may receive tocilizumab, which is given through a vein (intravenous). This medication may be used to manage certain side effects that can occur after receiving liso-cel.

    If needed, you may also receive rituximab, which is given by injection. This medication may also be used to help manage side effects.

    These medications will only be given if your medical team determines they are necessary based on how your body responds to the treatment.

  5. Step 5

    Additional medications during the study

    You may receive temozolomide, which is taken by mouth (oral). This is a medication that helps fight cancer cells.

    You may receive procarbazine, which is also taken by mouth (oral). This is another medication used to treat cancer.

    You may receive calcium folinate, which can be given by mouth (oral) or as a solution for injection. This medication helps protect healthy cells from the effects of certain cancer treatments.

    The specific medications you receive, their doses, how often you take them, and for how long will be determined by your medical team based on your individual situation and how you respond to treatment.

  6. Step 6

    Follow-up and monitoring period

    After receiving liso-cel, you will be monitored for 12 months to see if the cancer worsens or remains controlled.

    Your medical team will check for signs of cancer and assess how well the treatment is working.

    You will be observed for any health problems that may occur during the study, including how severe they are and how often they happen.

    The study will also evaluate how the treatment affects your quality of life and daily activities.

    Your participation in the study may continue beyond the initial 12 months, as the study is expected to continue until October 2028, depending on your individual response to treatment and overall health status.

Who can join the trial?

7 criteria

  • You must be 18 years or older
  • You must have a new diagnosis of Primary Central Nervous System Lymphoma, which is a type of cancer that affects the brain or spinal cord, and this diagnosis must be confirmed by laboratory tests
  • You cannot be eligible for ASCT, which stands for autologous stem cell transplant, a procedure where your own stem cells are used to replace damaged cells
  • You must be suitable to receive a treatment plan that includes HD-MTX, which is a high dose of a medication called methotrexate used to treat cancer
  • You must have been treated only with standard treatments before joining this study
  • Before agreeing to join the study, the signs of your cancer must be either completely gone or mostly gone
  • You must have an ECOG performance score of 0 to 2, which is a scale that measures how well you can perform daily activities. A score of 0 to 2 means you can take care of yourself and do most of your daily tasks, though you may have some limitations with work or strenuous activities

Who cannot join the trial?

5 criteria

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in this clinical trial
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent someone from joining this study
  • Exclusion criteria typically include factors such as other medical conditions, certain medications, or laboratory test results that might make the study unsafe or unsuitable for a patient
  • The trial is designed for patients with newly diagnosed Primary Central Nervous System Lymphoma, which is a type of cancer that affects the brain or spinal cord, who cannot have a procedure called autologous stem cell transplant, where a patient's own stem cells would be used for treatment
  • The study accepts both male and female adult and elderly patients
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lisocabtagene Maraleucel is a type of treatment called CAR T-cell therapy. This is a personalized medicine made from your own immune cells. Doctors collect some of your white blood cells and send them to a laboratory where they are modified to recognize and attack cancer cells. These modified cells are then given back to you through an infusion into your vein. In this trial, this treatment is being tested as a first treatment option for people with primary central nervous system lymphoma who cannot have a stem cell transplant.

What is already known about the treatment

Lisocabtagene Maraleucel – This is an advanced cell therapy treatment given as a one-time infusion directly into the bloodstream, where a patient's own immune cells are collected, modified in a laboratory to recognize and attack cancer cells, and then returned to the patient's body. It is currently being studied in clinical trials as a potential first-line treatment for Primary Central Nervous System Lymphoma in patients who cannot undergo stem cell transplantation. This medication works by genetically engineering the patient's T-cells to express special receptors that specifically target and destroy lymphoma cells, particularly those expressing a protein called CD19 on their surface. It belongs to a class of treatments called CAR-T cell therapies, which represent a form of personalized immunotherapy that harnesses the body's own immune system to fight cancer.

Investigated diseases

Primary Central Nervous System Lymphoma – Primary Central Nervous System Lymphoma is a rare type of cancer that begins in the lymph tissue of the brain or spinal cord. This disease occurs when white blood cells called lymphocytes become abnormal and grow uncontrollably within the central nervous system. The cancer cells typically form masses or tumors in the brain, eyes, or spinal fluid. As the disease progresses, the growing lymphoma can put pressure on brain structures and interfere with normal brain function. Patients may experience symptoms such as headaches, confusion, changes in personality, vision problems, seizures, or weakness in parts of the body. The condition primarily affects the central nervous system without spreading from other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521144-38-00Protocol codeCA082-1215Estimated enrolment55 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).