Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.

Study Overview

• Status: Enrolling by invitation
• Conditions: Solid and Hematological Malignancies
• Intervention / Treatment: Biological: Axicabtagene Ciloleucel; Biological: Brexucabtagene Autoleucel; Biological: KITE-363; Biological: Anitocabtagene autleucel; Biological: KITE-753; Biological: KITE-197

• Study Type: Observational
• Enrollment (Estimated): 1000
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Montreal, Canada, H4A 3J1
    • McGill University Health Center
  • Ottawa, Canada, K1YE9
    • The Ottawa Hospital - General Campus
  • Québec, Canada, G1J 1Z4
    • Hôpital de l'Enfant-Jésus
  • Toronto, Canada, M5G 1X8
    • The Hospital for Sick Children
  • Toronto, Canada, M5G 2C4
    • Princess Margaret Cancer Center - University Health Network
  • Vancouver, Canada, V5Z 1M9
    • Vancouver General Hospital
• France
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille
  • Montpellier, France, 34295
    • Hospital Saint Eloi
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Pessac, France, 33604
    • CHU Bordeaux, Hopital Haut-Leveque
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon-Sud
  • Rennes, France, 35033
    • Hopital Pontchaillou - CHU de Rennes
• Germany
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Heidelberg, Germany, 69120
    • Universittsklinikum Heidelberg
  • Mainz, Germany, 55101
    • Johannes Gutenberg University Hospital-University Mainz
  • München, Germany, 81377
    • LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin
• Israel
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Souraski Medical Center
• Italy
  • Milan, Italy, 20162
    • Asst Grande Ospedale Metropolitano Niguarda
  • Rome, Italy, 00165
    • Ospedale Pediatrico Bambino Gesu
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Sapporo Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
• Netherlands
  • Amsterdam, Netherlands, 1100
    • Amsterdam Universitair Medische Centra (UMC)
  • Groningen, Netherlands, 9700 RB
    • University Medical Centre Groningen
  • Nijmegen, Netherlands, 6525 GA
    • Radboud Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3011PL
    • Erasmus University Medical Centre (MC)
  • Utrecht, Netherlands, 3508 GA
    • UMC Utrecht
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08908
    • Institut Catalia d'Oncologia L'Hospitalet
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Istituto Oncologico Della Svizzera Italiana (IOSI)
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SW10 9NH
    • The Royal Marsden NHS Foundation Hospital
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
    • Palo Alto, California, United States, 94305
      • Stanford University
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Centre
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center Clinical Laboratories
    • Chicago, Illinois, United States, 60611
      • Ann& Robert H. Lurie Children's Hospital of Chicago
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center Westwood
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center Institute
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10029
      • Ichann School of Medicine at Mount Sinai
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Rochester, New York, United States, 55905
      • Mayo Clinic
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • DUHS-Duke Blood Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43220
      • James Cancer Hospital and Solove Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Austin, Texas, United States, 78704
      • St. David's Medical Center
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Sarah Cannon-Methodist Healthcare System - San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain LDS Hospita;/Blood and Marrow Transplant/ Acute Leukemia Program
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants who received an infusion of gene-modified cells and have not died, withdrawn consent, been withdrawn by the investigator, or been lost to follow-up at the time of transition from the completed parent study.

Description

Inclusion Criteria:

• The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
• The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
• In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

Exclusion Criteria: none

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Axicabtagene Ciloleucel (KTE-C19); All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: Axicabtagene Ciloleucel; No investigational product will be administered; Other Names: Yescarta®
Brexucabtagene Autoleucel (KTE-X19); All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: Brexucabtagene Autoleucel; No investigational product will be administered; Other Names: Tecartus™
Anitocabtagene autleucel; All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: Anitocabtagene autleucel; No investigational product will be administered; Other Names: CART-ddBCMA
KITE-753; All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: KITE-753; No investigational product will be administered
KITE-197; All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: KITE-197; No investigational product will be administered
KITE-363; All participants who previously received KITE-363 in the parent study will be enrolled in this cohort for long-term follow-up.	Biological: KITE-363; No investigational product will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height of Pediatric and Adolescent Participants		Up to 15 years
Weight of Pediatric and Adolescent Participants		Up to 15 years
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)	Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.	Up to 15 years
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)	Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.	Up to 15 years
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score	The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult.	Up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Subsequent Anticancer Therapies	Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.	Up to 15 years
Survival Status Assessment	Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.	Up to 15 years
Percentage of Participants With Cause of Death		Up to 15 years
Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)		Up to 15 years
Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product		Up to 15 years
Percentage of Participants With Status of Primary Malignant Disease		Up to 15 years

Collaborators and Investigators

• Sponsor: Kite, A Gilead Company
• Investigators: Study Director: Kite Study Director, Kite, A Gilead Company

Publications and helpful links

General Publications

• Munoz J, Locke FL, Reagan PM, Goy A, Jacobson CA, Hill BT, Timmerman JM, Flinn IW, Miklos DB, Pagel JM, Kersten MJ, Forcade E, Topp MS, Houot R, Beitinjaneh A, Zheng D, Chang M, Zhang W, Shen RR, Khalid RD, Kloos I, Wang ML. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026 Apr 27. doi: 10.1186/s13045-026-01797-4. Online ahead of print.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; brexucabtagene autoleucel; axicabtagene ciloleucel
• Other Study ID Numbers: KT-US-982-5968; 2020-005843-21 (EudraCT Number); MOH_2022-08-21_010606 (Registry Identifier: Israel Clinical Research Site); 2023-507041-28 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No