Menu
Enrolling by invitation NCT05041309

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

— Observational Solid and Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Axicabtagene Ciloleucel, Brexucabtagene Autoleucel, Anitocabtagene autleucel, KITE-753.
Who it may be relevant to
Registry conditions: Solid and Hematological Malignancies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Belgium, Canada +9
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Biological Axicabtagene Ciloleucel
    No investigational product will be administered
  • Biological Brexucabtagene Autoleucel
    No investigational product will be administered
  • Biological Anitocabtagene autleucel
    No investigational product will be administered
  • Biological KITE-753
    No investigational product will be administered
  • Biological KITE-197
    No investigational product will be administered
  • Biological KITE-363
    No investigational product will be administered

Primary outcome measures

  • Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) [Time frame: Up to 15 years]
  • Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) [Time frame: Up to 15 years]
  • Height of Pediatric and Adolescent Participants [Time frame: Up to 15 years]
  • Weight of Pediatric and Adolescent Participants [Time frame: Up to 15 years]
  • Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score [Time frame: Up to 15 years]
Secondary outcome measures (6)
  • Time to Subsequent Anticancer Therapies [Time frame: Up to 15 years]
  • Survival Status Assessment [Time frame: Up to 15 years]
  • Percentage of Participants With Cause of Death [Time frame: Up to 15 years]
  • Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) [Time frame: 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 [Time frame: Up to 15 years]
  • Percentage of Participants With Status of Primary Malignant Disease [Time frame: Up to 15 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 49 centers
  • Banner MD Anderson Cancer Center — Gilbert
  • City of Hope — Duarte
  • UC San Diego Moores Cancer Center — La Jolla
  • Children's Hospital Los Angeles — Los Angeles
  • University of California Los Angeles — Los Angeles
  • Children's Hospital of Orange County — Orange
  • Stanford University — Palo Alto
  • University of California Davis Comprehensive Cancer Center — Sacramento
  • … and 41 more centers
Canada · 6 centers
  • McGill University Health Center — Montreal
  • The Ottawa Hospital - General Campus — Ottawa
  • Hôpital de l'Enfant-Jésus — Québec
  • The hospital for sick children — Toronto
  • Princess Margaret Cancer Center - University Health Network — Toronto
  • Vancouver General Hospital — Vancouver
France · 6 centers
  • Centre Hospitalier Regional Universitaire de Lille — Lille
  • Hospital Saint Eloi — Montpellier
  • Hopital Saint-Louis — Paris
  • CHU Bordeaux, Hopital Haut-Leveque — Pessac
  • Centre Hospitalier Lyon-Sud — Pierre-Bénite
  • Hôpital Pontchaillou - CHU de Rennes — Rennes
Germany · 6 centers
  • Universitatsklinikum Carl Gustav Carus — Dresden
  • Universitätsklinikum Hamburg-Eppendorf — Hamburg
  • Universittsklinikum Heidelberg — Heidelberg
  • Johannes Gutenberg University Hospital-University Mainz — Mainz
  • LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III — München
  • Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin — Würzburg
Japan · 5 centers
  • Kyushu University Hospital — Fukuoka
  • Kyoto University Hospital — Kyoto
  • Okayama University Hospital — Okayama
  • Hokkaido University Hospital — Sapporo Hokkaido
  • National Cancer Center Hospital — Tokyo
Netherlands · 5 centers
  • Amsterdam Universitair Medische Centra (UMC) — Amsterdam
  • University Medical Centre Groningen — Groningen
  • … and 3 more centers
Spain · 4 centers

Center list to be confirmed — check the primary protocol.

Italy · 2 centers
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • Ospedale Pediatrico Bambino Gesu — Rome
United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Australia · 1 center
  • Peter MacCallum Cancer Centre — Melbourne
Austria · 1 center
  • Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie — Innsbruck
Belgium · 1 center
  • UZ Leuven — Leuven
Israel · 1 center
  • Tel Aviv Souraski Medical Center — Tel Aviv
Switzerland · 1 center

Center list to be confirmed — check the primary protocol.

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 2 PMID 42036693

Identifiers

NCT: NCT05041309 · KT-US-982-5968 · 2020-005843-21 · MOH_2022-08-21_010606 · 2023-507041-28

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗