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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Uwxwpylumn Mjxuvxo Ccvvzk Hakiotpeaqymsdiuh	Hamburg	Germany
Uazpvofiebkkkuskdaxqd Eknar Aue	Essen	Germany
Ujknblgikx Harplary Cwdhzaa	Cologne	Germany
Ckiftw Hxocbfhppuy Uvuipdlfjrzce Do Dllvf	Dijon	France
Ctdi Dc Niuyn	Vandoeuvre Les Nancy	France
Ijwhteio Pjckzlesiwsjtxu Cxefqa Cqrhgb	Marseille	France
Iezgomkn Cqdek	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.11.2025
Germany	Recruiting	03.11.2025

Trial locations

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.

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 ID:

2025-521144-38-00

Protocol code:

CA082-1215

NCT ID:

NCT07015242

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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