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Enrolling by invitation No phase listed Observational

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

ClinicalTrials.gov ID: NCT05041309

Public ClinicalTrials.gov record NCT05041309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 8:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05041309
Recruitment status
Enrolling by invitation
Study type
Observational
Phase
Not listed
Lead sponsor
Kite, A Gilead Company
Industry
Enrollment
1,500 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 15, 2021 (Actual)
Primary completion
Dec 2040 (Estimated)
Completion
Dec 2040 (Estimated)
Last update posted
Sep 21, 2026

2021 – 2040

United States locations

U.S. sites
49
U.S. states
24
U.S. cities
41
Facility City State ZIP Site status
Banner MD Anderson Cancer Center Gilbert Arizona 85234 —
City of Hope Duarte California 91010 —
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 —
Children's Hospital of Orange County Orange California 92868 —
Stanford University Palo Alto California 94305 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
University of California, San Francisco Medical Center San Francisco California 94143 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
Georgetown University Medical Center Washington D.C. District of Columbia 20007 —
Sylvester Comprehensive Cancer Centre Miami Florida 33136 —
Moffitt Cancer Center Tampa Florida 33612 —
Ann& Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
University of Chicago Medical Center Clinical Laboratories Chicago Illinois 60637 —
Loyola University Medical Center Maywood Illinois 60153 —
University of Iowa Iowa City Iowa 52242 —
The University of Kansas Cancer Center Westwood Westwood Kansas 66205 —
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Karmanos Cancer Center Institute Detroit Michigan 48201 —
Washington University St Louis Missouri 63110 —
University of Nebraska Omaha Nebraska 68198 —
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 —
Roswell Park Cancer Institute Buffalo New York 14263 —
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 Rochester Medical Center Rochester New York 14642 —
Mayo Clinic Rochester New York 55905 —
Montefiore Medical Center The Bronx New York 10467 —
DUHS-Duke Blood Cancer Center Durham North Carolina 27710 —
Cleveland Clinic Cleveland Ohio 44195 —
James Cancer Hospital and Solove Research Institute Columbus Ohio 43220 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Prisma Health Cancer Institute Greenville South Carolina 29615 —
Tennessee Oncology, PLLC Nashville Tennessee 37203 —
Vanderbilt University Nashville Tennessee 37232 —
St. David's Medical Center Austin Texas 78704 —
Baylor University Medical Center Dallas Texas 75246 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Sarah Cannon-Methodist Healthcare System - San Antonio San Antonio Texas 78229 —
Intermountain LDS Hospita;/Blood and Marrow Transplant/ Acute Leukemia Program Salt Lake City Utah 84143 —
University of Virginia Health System Charlottesville Virginia 22908 —
Virginia Commonwealth University Richmond Virginia 23219 —
Swedish Cancer Institute Seattle Washington 98104 —
Fred Hutchinson Cancer Center Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05041309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05041309 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →