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

May 13, 2026 updated by: Kite, A Gilead Company
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital Saint-Louis
      • Pessac, France, 33604
        • CHU Bordeaux, Hôpital Haut-Lévêque
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon-Sud
      • Rennes, France, 35033
        • Hopital Pontchaillou - CHU de Rennes
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum 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 Clínic 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height of Pediatric and Adolescent Participants
Time Frame: Up to 15 years
Up to 15 years
Weight of Pediatric and Adolescent Participants
Time Frame: Up to 15 years
Up to 15 years
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Time Frame: Up to 15 years
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)
Time Frame: Up to 15 years
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
Time Frame: Up to 15 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Subsequent Anticancer Therapies
Time Frame: Up to 15 years
Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Up to 15 years
Survival Status Assessment
Time Frame: Up to 15 years
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
Time Frame: Up to 15 years
Up to 15 years
Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
Time Frame: Up to 15 years
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
Up to 15 years
Percentage of Participants With Status of Primary Malignant Disease
Time Frame: Up to 15 years
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kite, A Gilead Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kite Study Director, Kite, A Gilead Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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