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Engineered immune cells take on brain cancer in pioneering trial

NCT ID NCT07015242

Disease control Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study is testing a new type of immunotherapy called liso-cel (Breyanzi) as the first treatment for primary central nervous system lymphoma (PCNSL), a rare brain cancer. The trial is for 65 adults who cannot have a stem cell transplant. Liso-cel is made from the patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The goal is to see if this approach can control the disease and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lisocabtagene maraleucel (liso-cel, Breyanzi) - a CAR T-cell therapy
What this could lead to
If successful, this could offer a new first-line treatment option for people with primary CNS lymphoma who cannot undergo a stem cell transplant, potentially improving disease control without the need for long-term chemotherapy.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 65 participants. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems. It is not yet known if it will work better than current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Participant must be 18 years or older at the time of signing the informed consent form (ICF). * Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology. * Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3. * Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen. * Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must be limited to HD-MTX based standard of care regimens with a minimum of 4 and maximum of 6 doses of MTX. Corticosteroids used as part of standard-of-care management for PCNSL symptom control are permitted prior to ICF signature but must be discontinued at the time of ICF signature. For medical conditions other than PCNSL, non-therapeutic corticosteroids use may be permitted on study. * Prior to enrollment, participant's disease must be sensitive to prior high-dose methotrexate-based (HD-MTX) regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * No prior experimental treatments for PCNSL. * Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention. Exclusion Criteria * Participant has a diagnosis of secondary CNS lymphoma due to systemic disease. * Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL), isolated cerebrospinal fluid (CSF) disease, or a relapsed or refractory PCNSL. * Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was to participate in the study based on investigator's judgement. * History of another primary malignancy that has not been in remission for ≥2 years. a. Exceptions include certain adequately treated non-invasive malignancies, localized prostate cancer treated with curative intent, and completely resected Stage 1 solid tumors with a low risk of recurrence. * Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology. * History of or active human immunodeficiency virus (HIV). * Active hepatitis B or active hepatitis C. * Active autoimmune disease requiring immunosuppressive therapy. * History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

lymphoma primary central nervous system lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU de Dijon Bourgogne - Hopital Francois Mitterand

    RECRUITING

    Dijon, 21079, France

  • CHU de Rennes - Hopital de Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 79038, France

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    RECRUITING

    Nantes, Loire-Atlantique, 44093 Cedex 1, France

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Chru De Lille - Hopital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Stuttgart - Katharinenhospital

    RECRUITING

    Stuttgart, 70174, Germany

  • Local Institution - 0102

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Local Institution - 0103

    NOT_YET_RECRUITING

    Pierre-Bénite, Rhône, 69495, France

  • Local Institution - 0108

    NOT_YET_RECRUITING

    Pessac, 33600, France

  • Local Institution - 0110

    NOT_YET_RECRUITING

    Saint-Cloud, 92210, France

  • Local Institution - 0111

    NOT_YET_RECRUITING

    Nice, Alpes-Maritimes, 06202, France

  • Local Institution - 0112

    NOT_YET_RECRUITING

    Marseille, 13273, France

  • Local Institution - 0114

    NOT_YET_RECRUITING

    Paris, 75010, France

  • Local Institution - 0115

    NOT_YET_RECRUITING

    Strasbourg, 67098, France

  • Local Institution - 0116

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Local Institution - 0202

    NOT_YET_RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Local Institution - 0207

    NOT_YET_RECRUITING

    Göttingen, 37075, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612-9416, United States

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sarah Cannon Research Institute Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43202-2224, United States

  • University Of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89070, Germany

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

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