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LymphomaPhase 2NCT07015242

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

A Phase 2 study testing Rituximab, Methotrexate and Procarbazine in people with Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 40 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Rituximab, Methotrexate and Procarbazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
40 sitesin 3 countries
Study dates
6 Nov 2025to 10 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
  • 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.
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  • 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.

Trial locations and contacts

40 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

40 sites in 3 countries

France16 sites, 16 recruiting

  • CHU de Dijon Bourgogne - Hopital Francois Mitterand

    Dijon, 21079

    Steeve CHEVREUX, Site 0106, 3330380295041

    Recruiting

  • Chru De Lille - Hopital Claude Huriez

    Lille, 59037

    Franck Morschhauser, Site 0113, 33320445713

    Recruiting

  • Local Institution - 0112

    Marseille, 13273

    Site 0112

    Not yet recruiting

  • CHU Montpellier

    Montpellier, 34295

    Charles Herbaux, Site 0107, +33467338364

    Recruiting

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

    Nantes, Loire-Atlantique, 44093 Cedex 1

    Benoit Tessoulin, Site 0104, +33240083271

    Recruiting

  • Local Institution - 0111

    Nice, Alpes-Maritimes, 06202

    Site 0111

    Not yet recruiting

  • Local Institution - 0114

    Paris, 75010

    Site 0114

    Not yet recruiting

  • Hopital Pitie-Salpetriere

    Paris, 75651

    Sylvain Choquet, Site 0102, 0033142162826

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-Leveque

    Pessac, 33600

    Francois-Xavier Gros, Site 0108, 33557656511

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69495

    Herve Ghesquieres, Site 0103, 33478864348

    Recruiting

  • CHU de Rennes - Hopital de Pontchaillou

    Rennes, 35033

    Roch Houot, Site 0101, 33299289873

    Recruiting

  • Centre Henri Becquerel

    Rouen, 79038

    Vincent Camus, Site 0105

    Recruiting

  • Institut Curie - site Saint-Cloud

    Saint-Cloud, 92210

    Adrien Gilbert, Site 0110

    Recruiting

  • CHU de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67098

    Luc-Matthieu Fornecker, Site 0115, +33368767373

    Recruiting

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

    Toulouse, 31059

    Lucie Oberic, Site 0109, 33531156353

    Recruiting

  • CHU de Nancy Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

    Arnaud CAMPIDELLI, Site 0116

    Recruiting

Other trials in France

United States14 sites, 14 recruiting

  • University Of Colorado

    Aurora, Colorado, 80045

    Bradley Haverkos, Site 0305, 513-543-8460

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Lakshmi Nayak, Site 0313, 617-632-2166

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Grant Schofield, Site 0310

    Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

    Reem Karmali, Site 0311, 312-695-0990

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Allison Winter, Site 0302, 216-445-4782

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43202-2224

    Nathan Denlinger, Site 0309

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Ayushi Chauhan, Site 0303

    Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

    Krish Patel, Site 0312, 206-215-2338

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Matt Matasar, Site 0315, 405-713-4950

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Michael Scordo, Site 0301, 646-608-4132

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sunita Nasta, Site 0304, 215-662-6933

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Vyshak Alva Venur, Site 0306

    Recruiting

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010

    Amanda Cashen, Site 0316, 314-454-8306

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9416

    Supreet Kaur, Site 0308

    Recruiting

Other trials in United States

Germany10 sites, 10 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

    Björn Chapuy, Site 0203

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

    Mathias Haenel, Site 0208, 4937133344500

    Recruiting

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

    Jan-Michel Heger, Site 0204

    Recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

    Bastian von Tresckow, Site 0206, +491631751277

    Recruiting

  • Local Institution - 0202

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Site 0202

    Not yet recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075

    Justin Hasenkamp, Site 0207, +495513966196

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Francis Ayuk, Site 0209

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

    Peter Dreger, Site 0210, 496221568008

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174

    Gerald Illerhaus, Site 0201, 01627456566

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89070

    Andreas Viardot, Site 0205, +49-73150045539

    Recruiting

Other trials in Germany

About this study

Official title: The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).

Conditions
Lymphoma
Being tested
Rituximab, Methotrexate, Procarbazine, Temozolomide, Liso-cel
Keywords
primary CNS lymphoma, newly diagnosed, JCAR017
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Specified dose on specified days

  • MethotrexateDrug

    Specified dose on specified days

  • ProcarbazineDrug

    Specified dose on specified days

  • TemozolomideDrug

    Specified dose on specified days

  • Liso-celBiological

    Also called JCAR017, Breyanzi

    Specified dose on specified days

  • FludarabineDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

  • Calcium folinateDrug

    Also called Leucovorin

    Specified dose on specified days

Study groups in NCT07015242
Study groupRoleWhat they receive
Liso-cel AdministrationExperimentalNot described
Receives: Drug: Rituximab; Drug: Methotrexate; Drug: Procarbazine; Drug: Temozolomide; Biological: Liso-cel; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Calcium folinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first

    Measured: 12 months after liso-cel infusion

Secondary outcomes (15)

  1. PFS

    Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first

    Measured: 12 months after date of enrollment

  2. Modified Progression-free Survival (mPFS)

    Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first. Disease relapse or progression prior to liso-cel infusion is considered as an event only if the patient does not achieve complete response (CR) after liso-cel infusion.

    Measured: 12 months after date of enrollment

  3. Complete Response Rate (CRR)

    Defined as proportion of patients achieving CR at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat Primary Central Nervous System Lymphoma (PCNSL), or end of study, whichever occurs first

    Measured: Up to end of study (approximately 2 years)

  4. Overall Response Rate (ORR)

    Defined as proportion of patients achieving CR or Partial Response (PR) at any time between liso-cel infusion and the date of first documented disease relapse or progression as assessed by the investigator, initiation of a new antineoplastic therapy to treat PCNSL, or end of study, whichever occurs first

    Measured: Up to end of study (approximately 2 years)

  5. Duration of Response (DoR)

    Defined as the time from the date of first documented disease response (complete response [CR] or partial response [PR]) achieved after liso-cel infusion to the date of first subsequent documented disease relapse or progression as assessed by the investigator, or death from any cause

    Measured: 12 months after liso-cel infusion

  6. Event-free Survival (EFS)

    Defined as the time from the date of enrollment to the date of first documented disease relapse or progression as assessed by the investigator, or initiation of new antineoplastic therapy to treat PCNSL, or death from any cause, whichever occurs first

    Measured: 12 months after date of enrollment

  7. Overall Survival (OS)

    Defined as the time from the date of enrollment to the date of death from any cause

    Measured: 12 months after date of enrollment

  8. Number of participants with adverse events (AEs)

    Measured: Up to end of study (approximately 2 years)

  9. Number of participants with serious adverse events (SAEs)

    Measured: Up to end of study (approximately 2 years)

  10. Number of participants with adverse events of special interest (AESIs)

    Measured: Up to end of study (approximately 2 years)

  11. Number of participants with laboratory abnormalities

    Measured: Up to end of study (approximately 2 years)

  12. Health-related quality of life (HRQoL)

    As assessed by the European Organisation for Research and Treatment of Cancer--Quality of Life C30 Questionnaire (EORTC-QLQ-30)

    Measured: Up to end of study (approximately 2 years)

  13. Health-related quality of life (HRQoL)

    As assessed by the European Organisation for Research and Treatment of Cancer--Quality of Life BN20 Questionnaire (EORTC-QLQ-BN20)

    Measured: Up to end of study (approximately 2 years)

  14. Neurocognitive performance (Trial Making Test - Parts A and B)

    Change from baseline over time in neurocognitive functions assessed using the Trail Making Test (TMT)

    Measured: Up to end of study (approximately 2 years)

  15. Neurocognitive performance (Montreal Cognitive Assessment (MoCA))

    Change from baseline over time in neurocognitive functions assessed using the Montreal Cognitive Assessment (MoCA)

    Measured: Up to end of study (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start6 Nov 2025
  3. Primary completion9 Jan 2028 (estimated)
  4. Study completion10 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015242
Sponsor's protocol ID
CA082-1215
Other IDs
2025-521144-38, U1111-1318-3732, 2025
Status last verified
Nov 2026
First submitted
3 Jun 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Methotrexate and Procarbazine in people with Lymphoma, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 40 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 12 months after liso-cel infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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