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Immune cell therapy takes on hard-to-treat lymphoma in major trial

NCT ID NCT05371093

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a personalized cell therapy (axicabtagene ciloleucel) works better than standard treatments for people with follicular lymphoma that has come back or stopped responding. About 231 adults with this slow-growing blood cancer will receive either the cell therapy or usual care. The main goal is to see how long the cancer stays away.

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

231 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Oct 2030

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 follicular lymphoma (FL) (Grade 1, 2, or 3a) * Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy * Clinical indication for treatment. * At least 1 measurable lesion per the Lugano Classification {Cheson 2014} * Adequate renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: * Presence of large B cell lymphoma or transformed FL * Small lymphocytic lymphoma * Lymphoplasmacytic lymphoma * Full-thickness involvement of the gastric wall by lymphoma * FL Grade 3b * Prior CD19-targeted therapy * Prior CAR therapy or other genetically modified T-cell therapy * Uncontrolled fungal, bacterial, viral, or other infection * Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus * History or presence of a clincially significant central nervous system (CNS) disorder. * History of autoimmune disease * Known history or CNS lymphoma involvement * Cardiac lymphoma involvement * History of clinically significant cardiac disease 6 months before randomization * Neuropathy greater than grade 2 * Females who are pregnant or breastfeeding * Individuals of both genders who are not willing to practice birth control * Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

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

Relapsed/refractory follicular lymphoma

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    Bergamo, 24128, Italy

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

    Bologna, 40138, Italy

  • CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

    Pessac, 33604, France

  • CHU de Dijon

    Dijon, 21079, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 2QQ, United Kingdom

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS - Istituto Nazionale Tumori

    Milan, 20100, Italy

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Pitie-Salpetriere

    Paris, 75013, France

  • Hopital Pontchaillou - CHU Rennes

    Rennes, 35033, France

  • Hopital Saint Eloi

    Montpellier, 34295, France

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501, Japan

  • Hôpital Claude Huriez-CHU de Lille

    Lille, 59037, France

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)

    Barcelona, 08908, Spain

  • Istituto Clinico Humanitas-IRCCS

    Rozzano, 20089, Italy

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Novant Health Cancer Institute Hematology - Charlotte

    Charlotte, North Carolina, 28204, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka University Hospital

    Osaka, 565-0871, Japan

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Stanford Health Care

    Stanford, California, 94305, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • The University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • 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

  • TriStar Centennial Medical Center - Cell Processing

    Nashville, Tennessee, 37203, United States

  • Universitatsklinikum Koln Klinik I fur Innere Medizin

    Würzburg, 97080, Germany

  • Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW2 2QG, United Kingdom

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566,, Japan

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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