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CAR-T therapy takes on High-Risk lymphoma as First-Line treatment

NCT ID NCT05605899

Disease control Sponsor: Kite, A Gilead Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing whether a single infusion of a patient's own genetically modified immune cells (CAR-T therapy, called Yescarta) works better than standard chemotherapy plus antibody treatment as the very first therapy for people with high-risk large B-cell lymphoma. About 300 participants will be randomly assigned to receive either the CAR-T cells or standard care. The main goal is to see if the CAR-T approach delays disease progression or death better than the usual treatment.

What this could mean

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

Active substance
Axicabtagene ciloleucel (Yescarta), a CAR-T cell therapy made from the patient's own immune cells
What this could lead to
If successful, this could offer a more effective first-line treatment for people with high-risk large B-cell lymphoma, potentially improving event-free survival and overall survival.
What could go wrong
This is an early-phase 3 trial with 300 participants, so results may not apply to all patients. CAR-T therapy carries risks of severe side effects like cytokine release syndrome and neurological problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Started

Feb 2023

Expected to finish

Mar 2031

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.

Key Inclusion Criteria: * Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following: * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) * High-grade B-cell lymphoma (HGBL) * Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen. * High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis. * Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy). * Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. * Females of childbearing potential must have a negative serum or urine pregnancy test. Key Exclusion Criteria: * The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia * Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma. * Presence of cardiac lymphoma involvement. * Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy. * History of severe immediate hypersensitivity reaction to any of the agents used in this study. * Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment. * History of acute or chronic active hepatitis B or C infection. * Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count \> 200 cells/uL. * Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details. * History of clinically significant cardiac disease within 12 months before enrollment. * History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma high grade B-cell lymphoma

As listed by the trial registrant

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

High-risk large B-cell lymphoma (LBCL)

Contacts and locations

Locations

  • ASST Degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Academisch Medisch Centrum

    Amsterdam, 1081HV, Netherlands

  • Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust)

    Birmingham, B15 2TH, United Kingdom

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

    Perugia, 06132, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHU Bordeaux-Hopital Haut-Leveque

    Bordeaux, France

  • CHU Dijon

    Dijon, 21079, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Universitaire de Nice

    Nice, CS 23079, France

  • Centre Hospitalier Universitaire(CHU) de Toulouse

    Toulouse, 31100, France

  • Centre Leon Berard

    Cedex Lyon 08, 69008, France

  • Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, Portugal

  • Charite Universitaetsmedizin Berlin

    Berlin, Germany

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli

    Reggio Calabria, 89133, Italy

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232, United States

  • Hopital Claude Huriez CHU Lille, Service Maladies du sang

    Lille, 59037, France

  • Hopital Henri MONDOR, APHP

    Paris, 94000, France

  • Hopital Saint Eloi

    Montpellier, 34295, France

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138, Italy

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E.

    Lisbon, Portugal

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072, Portugal

  • Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program

    Salt Lake City, Utah, 84143, United States

  • Jewish General Hospital

    Montreal, H3T1E2, Canada

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Maastricht Universitair Medisch Centrum

    Maastricht, 62002, Netherlands

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Cancer Center Outpatient Pharmacy

    Rochester, Minnesota, 55902, United States

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna)

    Vienna, 01090, Austria

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60612, United States

  • Norton Cancer Institute, St. Matthews Campus

    Shelbyville, Kentucky, 40065, United States

  • Novant Health Cancer Institute- Hematology

    Charlotte, North Carolina, 28204, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9, Canada

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29615, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203, United States

  • Royal Brisbane and Women's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • The Ottowa Hospital- General Campus

    Ottawa, K1H 8L6, Canada

  • The University of Kansas Hospital

    Westwood, Kansas, 66205, United States

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokyo Metropolitan Komagome Hospital

    Tokyo, 113-8677, Japan

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie

    Düsseldorf, 40225, Germany

  • Universita Cattolica del Sacro Cuore

    Rome, Italy

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3508 GA, Netherlands

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566,, Japan

  • University Hospitals Southampton

    Southampton, SO16 6YD, United Kingdom

  • University Medical Center Groningen

    Groningen, 9700 RB, Netherlands

  • University of Alabama Hospital

    Birmingham, Alabama, 35233, United States

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of MD Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • Universitätsklinik Erlangen

    Erlangen, Germany

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100, Austria

  • Universitätsklinikum bonn, medizinische klinik III

    Bonn, 53127, Germany

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Weill Cornell Medical College - NewYork Presbyterian Hospital

    New York, New York, 10021, United States

  • Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU

    Salzburg, 5020, Austria

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Other studies related to the condition(s) this trial covers.