Clinical trial Phase 3 Interventional Ages 18 and up

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Run by Kite, A Gilead Company · NCT05371093 · Data updated 2026-11-12

Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2030-10.

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment231 (actual)
SponsorKite, A Gilead Company
Industry-sponsored
Drugs / interventionsAxicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab, Doxorubicin, Vincristine, Prednisone, Bendamustine
Locations52 sites (France, Germany, Italy, Japan, Spain, United Kingdom, United States)
Trial IDNCT05371093 on ClinicalTrials.gov

What this trial studies

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Duarte, California, United States
  • Stanford Health Care
    Stanford, California, United States
  • Moffitt Cancer Center
    Tampa, Florida, United States
  • The University of Kansas Hospital
    Westwood, Kansas, United States
  • University of Maryland Greenebaum Comprehensive Cancer Center
    Baltimore, Maryland, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
Show 44 more locations
  • Novant Health Cancer Institute Hematology - Charlotte
    Charlotte, North Carolina, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania, United States
  • TriStar Centennial Medical Center - Cell Processing
    Nashville, Tennessee, United States
  • Henry-Joyce Cancer Clinic
    Nashville, Tennessee, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States
  • Virginia Commonwealth University
    Richmond, Virginia, United States
  • Hopital Henri Mondor
    Créteil, France
  • CHU de Dijon
    Dijon, France
  • Hôpital Claude Huriez-CHU de Lille
    Lille, France
  • Institut Paoli-Calmettes
    Marseille, France
  • Hopital Saint Eloi
    Montpellier, France
  • Hopital Pitie-Salpetriere
    Paris, France
  • CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
    Pessac, France
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, France
  • CHU de Poitiers
    Poitiers, France
  • Hopital Pontchaillou - CHU Rennes
    Rennes, France
  • Centre Henri Becquerel
    Rouen, France
  • Universitatsmedizin Gottingen
    Göttingen, Germany
  • Universitatsklinikum Koln Klinik I fur Innere Medizin
    Würzburg, Germany
  • ASST Papa Giovanni XXIII
    Bergamo, Italy
  • Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
    Bologna, Italy
  • Fondazione IRCCS - Istituto Nazionale Tumori
    Milan, Italy
  • Ospedale San Raffaele
    Milan, Italy
  • Arcispedale Santa Maria Nuova
    Reggio Emilia, Italy
  • Istituto Clinico Humanitas-IRCCS
    Rozzano, Italy
  • Hyogo Medical University Hospital
    Hyōgo, Japan
  • University Hospital Kyoto Prefectural University of Medicine
    Kyoto, Japan
  • Tohoku University Hospital
    Miyagi, Japan
  • Okayama University Hospital
    Okayama, Japan
  • Osaka University Hospital
    Osaka, Japan
  • Hospital Universitari Vall d'Hebrón
    Barcelona, Spain
  • Hospital Clinic de Barcelona
    Barcelona, Spain
  • Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
    Barcelona, Spain
  • Hospital General Universitario Gregorio Maranon
    Madrid, Spain
  • Hospital 12 de Octubre
    Madrid, Spain
  • Hospital Universitario de Salamanca
    Salamanca, Spain
  • Hospital Universitario Virgen del Rocio
    Seville, Spain
  • Hospital Clínico Universitario de Valencia
    Valencia, Spain
  • University Hospital Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom
  • King's College Hospital NHS Foundation Trust
    London, United Kingdom
  • The Christie NHS Foundation Trust
    Manchester, United Kingdom
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, United Kingdom

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Kite Study Director — Kite, A Gilead Company

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.