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Solid and Hematological MalignanciesNCT05041309

Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies

An observational study of Solid and Hematological Malignancies and Autoimmune Diseases, run by Kite, A Gilead Company at 91 sites in 14 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored… Read more about this study

Who is it for?
Any age
What is being tested?
Axicabtagene Ciloleucel, Brexucabtagene Autoleucel and Anitocabtagene autleucel
How many people
1,500 participants
Where
91 sitesin 14 countries
Study dates
15 Dec 2021to Dec 2040
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The participants who received an infusion of gene-modified cells and have not died, withdrawn consent, been withdrawn by the investigator, or been lost to follow-up at the time of transition from the completed parent study.

Who may be able to join

  • The individual must have been administered gene-modified cell therapy 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

Who cannot join

None listed.

Trial locations and contacts

91 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

91 sites in 14 countries

United States49 sites

  • St. David's Medical Center

    Austin, Texas, 78704

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60611

  • University of Chicago Medical Center Clinical Laboratories

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43220

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Karmanos Cancer Center Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • DUHS-Duke Blood Cancer Center

    Durham, North Carolina, 27710

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29615

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Sylvester Comprehensive Cancer Centre

    Miami, Florida, 33136

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Ichann School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska

    Omaha, Nebraska, 68198

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Stanford University

    Palo Alto, California, 94305

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Mayo Clinic

    Rochester, New York, 55905

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

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

    Salt Lake City, Utah, 84143

  • Sarah Cannon-Methodist Healthcare System - San Antonio

    San Antonio, Texas, 78229

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • The University of Kansas Cancer Center Westwood

    Westwood, Kansas, 66205

Other trials in United States

Canada6 sites

  • McGill University Health Center

    Montreal, H4A 3J1

  • The Ottawa Hospital - General Campus

    Ottawa, K1YE9

  • Hôpital de l'Enfant-Jésus

    Québec, G1J 1Z4

  • The hospital for sick children

    Toronto, M5G 1X8

  • Princess Margaret Cancer Center - University Health Network

    Toronto, M5G 2C4

  • Vancouver General Hospital

    Vancouver, V5Z 1M9

Other trials in Canada

France6 sites

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037

  • Hospital Saint Eloi

    Montpellier, 34295

  • Hopital Saint-Louis

    Paris, 75010

  • CHU Bordeaux, Hopital Haut-Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Hôpital Pontchaillou - CHU de Rennes

    Rennes, 35033

Other trials in France

Germany6 sites

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universittsklinikum Heidelberg

    Heidelberg, 69120

  • Johannes Gutenberg University Hospital-University Mainz

    Mainz, 55101

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

    München, 81377

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

    Würzburg, 97080

Other trials in Germany

Japan6 sites

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Okayama University Hospital

    Okayama, 700-8558

  • Hokkaido University Hospital

    Sapporo Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, 980-8574

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

Netherlands5 sites

  • Amsterdam Universitair Medische Centra (UMC)

    Amsterdam, 1100

  • University Medical Centre Groningen

    Groningen, 9700 RB

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • Erasmus University Medical Centre (MC)

    Rotterdam, 3011PL

  • UMC Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catalia d'Oncologia L'Hospitalet

    Barcelona, 08908

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Italy2 sites

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Pediatrico Bambino Gesu

    Rome, 00165

Other trials in Italy

United Kingdom2 sites

  • King's College Hospital

    London, SE5 9RS

  • The Royal Marsden NHS Foundation Hospital

    London, SW10 9NH

Other trials in United Kingdom

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

Austria1 site

  • Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

    Innsbruck, 6020

Other trials in Austria

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Israel1 site

  • Tel Aviv Souraski Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Switzerland1 site

  • Istituto Oncologico Della Svizzera Italiana (IOSI)

    Bellinzona, 6500

Other trials in Switzerland

About this study

Official title: 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, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies.

The primary objectives of this study are to:

  • Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality)
  • Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.
Being tested
Axicabtagene Ciloleucel, Brexucabtagene Autoleucel, Anitocabtagene autleucel, KITE-753, KITE-197
Medical subject headings
Hematologic Neoplasms, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axicabtagene CiloleucelBiological

    Also called Yescarta®

    No investigational product will be administered

  • Brexucabtagene AutoleucelBiological

    Also called Tecartus™

    No investigational product will be administered

  • Anitocabtagene autleucelBiological

    Also called CART-ddBCMA

    No investigational product will be administered

  • KITE-753Biological

    No investigational product will be administered

  • KITE-197Biological

    No investigational product will be administered

  • KITE-363Biological

    No investigational product will be administered

  • INT2104Biological

    No investigational product will be administered

  • KITE-512Biological

    No investigational product will be administered

  • SPRX001Biological

    No investigational product will be administered

  • SPRX002Biological

    No investigational product will be administered

  • ARC-T CellsBiological

    No investigational product will be administered

Study groups in NCT05041309
Study groupRoleWhat they receive
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.
Receives: Biological: Axicabtagene Ciloleucel
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.
Receives: Biological: Brexucabtagene Autoleucel
Anitocabtagene autleucelAll participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: Anitocabtagene autleucel
KITE-753All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: KITE-753
KITE-197All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: KITE-197
KITE-363: Oncology IndicationAll participants who previously received KITE-363 for oncology indication in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: KITE-363
KITE-363: Autoimmune IndicationAll participants who previously received KITE-363 for autoimmune indication in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: KITE-363
INT2104All participants who previously received INT2104 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: INT2104
KITE-512All participants who previously received KITE-512 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: KITE-512
ACLX-001 (SPRX001 + ARC-T cells)All participants who previously received ACLX-001 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: SPRX001; Biological: ARC-T Cells
ACLX002 (SPRX002 + ARC-T cells)All participants who previously received ACLX-002 in the parent study will be enrolled in this cohort for long-term follow-up.
Receives: Biological: SPRX002; Biological: ARC-T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, and serious infections.

    Measured: Up to 15 years

  2. 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, and serious infections.

    Measured: Up to 15 years

  3. Percentage of Participants With New Malignancies

    New malignancies regardless of causality includes time to development of the new malignancy, type, location, staging, and molecular mechanism (including testing for presence of the CAR transgene and (replication-competent retrovirus/replication-competent lentivirus (RCR/RCL)). Also to assess the occurrence of all related SAEs that do not fall under the umbrella of targeted events.

    Measured: Up to 15 years

  4. Percentage of Participants Experiencing Related SAEs

    Adverse events which might be possibly related to the treatment drugs.

    Measured: Up to 15 years

  5. Height of Pediatric and Adolescent Participants

    Measured: Up to 15 years

  6. Weight of Pediatric and Adolescent Participants

    Measured: Up to 15 years

  7. 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.

    Measured: Up to 15 years

Secondary outcomes (6)

  1. Time to Subsequent Anticancer Therapies

    Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.

    Measured: Up to 15 years

  2. 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.

    Measured: Up to 15 years

  3. Percentage of Participants With Cause of Death

    Measured: Up to 15 years

  4. Overall Rate of Replication-competent RCR/RCL

    Measured: Up to 15 years

  5. Percentage of Participants With Vector Integration Site(s) for RCR/RCL or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product

    Measured: Up to 15 years

  6. Percentage of Participants With Status of Primary Malignant Disease

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start15 Dec 2021
  3. Primary completionDec 2040 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041309
Sponsor's protocol ID
KT-US-982-5968
Other IDs
2020-005843-21, MOH_2022-08-21_010606, 2023-507041-28, 2023
Status last verified
Sep 2026
First submitted
27 Aug 2021
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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;19(1):39. doi: 10.1186/s13045-026-01797-4.

    PubMed 42036693

Questions about this trial

What is this clinical trial studying?

An observational study of Solid and Hematological Malignancies and Autoimmune Diseases, run by Kite, A Gilead Company at 91 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Canada, France, Germany, Japan and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) (time frame: Up to 15 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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