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

NCT ID: NCT05041309

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid and Hematological Malignancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Axicabtagene Ciloleucel

Intervention Type BIOLOGICAL

No investigational product will be administered

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.

Brexucabtagene Autoleucel

Intervention Type BIOLOGICAL

No investigational product will be administered

Anitocabtagene autleucel

All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.

Anitocabtagene autleucel

Intervention Type BIOLOGICAL

No investigational product will be administered

KITE-753

All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.

KITE-753

Intervention Type BIOLOGICAL

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.

KITE-197

Intervention Type BIOLOGICAL

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.

KITE-363

Intervention Type BIOLOGICAL

No investigational product will be administered

Interventions

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Axicabtagene Ciloleucel

No investigational product will be administered

Intervention Type BIOLOGICAL

Brexucabtagene Autoleucel

No investigational product will be administered

Intervention Type BIOLOGICAL

Anitocabtagene autleucel

No investigational product will be administered

Intervention Type BIOLOGICAL

KITE-753

No investigational product will be administered

Intervention Type BIOLOGICAL

KITE-197

No investigational product will be administered

Intervention Type BIOLOGICAL

KITE-363

No investigational product will be administered

Intervention Type BIOLOGICAL

Other Intervention Names

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Yescarta® Tecartus™ CART-ddBCMA

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kite, A Gilead Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kite Study Director

Role: STUDY_DIRECTOR

Kite, A Gilead Company

Locations

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Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

University of California, San Francisco Medical Center

San Francisco, California, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Sylvester Comprehensive Cancer Centre

Miami, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Ann& Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center Clinical Laboratories

Chicago, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

The University of Kansas Cancer Center Westwood

Westwood, Kansas, United States

Site Status

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Center Institute

Detroit, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Nebraska

Omaha, Nebraska, United States

Site Status

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Ichann School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Mayo Clinic

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

DUHS-Duke Blood Cancer Center

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Site Status

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute

Greenville, South Carolina, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Sarah Cannon-Methodist Healthcare System - San Antonio

San Antonio, Texas, United States

Site Status

Intermountain LDS Hospita;/Blood and Marrow Transplant/ Acute Leukemia Program

Salt Lake City, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

Innsbruck, , Austria

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

McGill University Health Center

Montreal, , Canada

Site Status

The Ottawa Hospital - General Campus

Ottawa, , Canada

Site Status

Hôpital de l'Enfant-Jésus

Québec, , Canada

Site Status

The hospital for sick children

Toronto, , Canada

Site Status

Princess Margaret Cancer Center - University Health Network

Toronto, , Canada

Site Status

Vancouver General Hospital

Vancouver, , Canada

Site Status

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Site Status

Hospital Saint Eloi

Montpellier, , France

Site Status

Hopital Saint-Louis

Paris, , France

Site Status

CHU Bordeaux, Hopital Haut-Leveque

Pessac, , France

Site Status

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status

Hôpital Pontchaillou - CHU de Rennes

Rennes, , France

Site Status

Universitatsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Universittsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Johannes Gutenberg University Hospital-University Mainz

Mainz, , Germany

Site Status

LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III

München, , Germany

Site Status

Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin

Würzburg, , Germany

Site Status

Tel Aviv Souraski Medical Center

Tel Aviv, , Israel

Site Status

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Kyushu University Hospital

Fukuoka, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Hokkaido University Hospital

Sapporo Hokkaido, , Japan

Site Status

National Cancer Center Hospital

Tokyo, , Japan

Site Status

Amsterdam Universitair Medische Centra (UMC)

Amsterdam, , Netherlands

Site Status

University Medical Centre Groningen

Groningen, , Netherlands

Site Status

Radboud Universitair Medisch Centrum

Nijmegen, , Netherlands

Site Status

Erasmus University Medical Centre (MC)

Rotterdam, , Netherlands

Site Status

UMC Utrecht

Utrecht, , Netherlands

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Institut Catalia d'Oncologia L'Hospitalet

Barcelona, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Istituto Oncologico Della Svizzera Italiana (IOSI)

Bellinzona, , Switzerland

Site Status

King's College Hospital

London, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Hospital

London, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Canada France Germany Israel Italy Japan Netherlands Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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2020-005843-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOH_2022-08-21_010606

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-507041-28

Identifier Type: OTHER

Identifier Source: secondary_id

KT-US-982-5968

Identifier Type: -

Identifier Source: org_study_id

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