RecruitingPHASE2INTERVENTIONAL

A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma

This research study is investigating a new treatment called 'liso-cel' (also known as Breyanzi) for adults who have a specific type of cancer called Primary Central Nervous System Lymphoma (PCNSL). This is a lymphoma that affects the brain or spinal cord. The study focuses on patients who are not suitable for a stem cell transplant, often due to their age or other health conditions. Researchers want to find out if liso-cel is a safe and effective 'first-line' treatment for these patients, meaning it's the first main treatment they receive for their condition. Other standard treatments like chemotherapy drugs (Rituximab, Methotrexate, Procarbazine, Temozolomide) might also be involved.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrolment target

Start

06 Nov 2025

Estimated completion

10 Dec 2028

Lymphoma

What is this study about?

This study is about a type of cancer called Primary Central Nervous System Lymphoma, or PCNSL. This is a lymphoma that starts in the brain or spinal cord. When someone is diagnosed with PCNSL, doctors usually recommend a treatment plan, which might include strong chemotherapy or even a stem cell transplant. However, not everyone can have a stem cell transplant, perhaps because they are older or have other health issues.

This research is looking at a new treatment called 'liso-cel' (you might also hear it called Breyanzi). It's a type of treatment that uses the patient's own immune cells, which are specially modified in a laboratory to find and attack cancer cells. The main goal is to see if liso-cel can be a safe and effective option as the very first treatment for adults with PCNSL who can't have a stem cell transplant.

The study is in 'Phase 2,' which means it's testing the treatment in a larger group of people to see how well it works and to continue checking its safety. This research is important because it could offer a new and potentially better treatment option for patients with PCNSL who currently have limited choices.

Key takeaways

This study is for adults with a brain or spinal cord lymphoma called PCNSL.
It's for those who cannot have a stem cell transplant.
It's testing a new 'immune cell' treatment called liso-cel.
The aim is to see if liso-cel is a safe and effective first treatment option.
Patients will receive close medical monitoring throughout the study.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have a confirmed diagnosis of Primary Central Nervous System Lymphoma (PCNSL) that started in your brain or spinal cord. You must also be considered unsuitable for a stem cell transplant, which usually means being 65 or older, or having certain other health conditions.

Before joining, you will have likely received some initial chemotherapy treatment for your PCNSL, typically with a drug called high-dose methotrexate. Your doctors would need to confirm that your cancer responded well to this initial treatment, meaning it either completely disappeared or mostly went away. You also need to be fit enough for treatment, usually described as having a good performance status.

However, you wouldn't be able to join if your lymphoma spread to your brain from another part of your body (secondary CNS lymphoma), or if your lymphoma is only in your eyes or spinal fluid, or if your PCNSL has come back or isn't responding to treatment. The doctors will check your overall health carefully to make sure you are suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have Primary Central Nervous System Lymphoma (PCNSL)?
Have your doctors said you are not suitable for a stem cell transplant?
Did your PCNSL respond well to initial chemotherapy (e.g., high-dose methotrexate)?
Are you generally fit enough for medical treatment?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the new treatment called liso-cel. This involves several steps: first, some of your blood will be collected so that your immune cells can be specially prepared in a lab. You will also receive some traditional chemotherapy (like fludarabine and cyclophosphamide) to prepare your body for the liso-cel treatment. After this, the specially prepared liso-cel cells will be given back to you through a drip.

Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits and the total duration aren't specified here, but clinical trials usually involve frequent close monitoring for several months, followed by longer-term follow-up.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new and innovative treatment that might be more effective than existing options, or receiving very close medical monitoring. However, there are also potential risks. The new treatment, liso-cel, and the chemotherapy drugs involved can have side effects, some of which may be serious. Your doctors will explain all known side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (40)

University Of Colorado
Verified postcode
Aurora, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Verified postcode
Chicago, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Washington University School of Medicine in St. Louis
Verified postcode
St Louis, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States· Recruiting
Roswell Park Comprehensive Cancer Center
Verified postcode
Buffalo, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
The Ohio State University Comprehensive Cancer Center
Verified postcode
Columbus, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Sarah Cannon Research Institute Oncology Partners
Verified postcode
Nashville, United States· Recruiting

Common questions

What is PCNSL?

PCNSL stands for Primary Central Nervous System Lymphoma. It's a type of cancer that starts in the brain or spinal cord.

What is liso-cel?

Liso-cel (Breyanzi) is a new type of treatment that uses your own immune cells, specially trained to fight cancer.

What does 'transplant-ineligible' mean?

It means you're not suitable for a stem cell transplant, often due to age (e.g., 65 or older) or other health issues.

What is a Phase 2 study?

A Phase 2 study tests a new treatment in a larger group of people to see how well it works and to continue checking its safety.

Will I still get some chemotherapy?

Yes, even with the new liso-cel treatment, you may receive some chemotherapy drugs during the study.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.