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

NCT05041309 · tracked via the Priya Life Science Japan tracker

Sponsor

Kite, A Gilead Company

Phase

Observational

Started

2021-12-15

Last updated

2026-09-21

Condition(s) studied

Solid and Hematological MalignanciesAutoimmune Diseases

Investigational drug(s) / intervention(s)

Axicabtagene Ciloleucel →Brexucabtagene Autoleucel →Anitocabtagene autleucel →KITE-753 →KITE-197 →KITE-363 →INT2104KITE-512SPRX001SPRX002 →ARC-T Cells

Axicabtagene Ciloleucel: No investigational product will be administered

Brexucabtagene Autoleucel: No investigational product will be administered

Anitocabtagene autleucel: No investigational product will be administered

KITE-753: No investigational product will be administered

KITE-197: No investigational product will be administered

KITE-363: No investigational product will be administered

INT2104: No investigational product will be administered

KITE-512: No investigational product will be administered

SPRX001: No investigational product will be administered

SPRX002: No investigational product will be administered

ARC-T Cells: No investigational product will be administered

Study 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 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: none

Primary outcome measure(s)

Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) — 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, and serious infections.
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) — 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, and serious infections.
Percentage of Participants With New Malignancies — Up to 15 years
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.
Percentage of Participants Experiencing Related SAEs — Up to 15 years
Adverse events which might be possibly related to the treatment drugs.
Height of Pediatric and Adolescent Participants — Up to 15 years
Weight of Pediatric and Adolescent Participants — Up to 15 years
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score — 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.

Trial sites (91)

Facility	City	Region
Banner MD Anderson Cancer Center	Gilbert	Arizona
City of Hope	Duarte	California
UC San Diego Moores Cancer Center	La Jolla	California
Children's Hospital Los Angeles	Los Angeles	California
University of California Los Angeles	Los Angeles	California
Children's Hospital of Orange County	Orange	California
Stanford University	Palo Alto	California
University of California Davis Comprehensive Cancer Center	Sacramento	California
University of California, San Francisco Medical Center	San Francisco	California
Colorado Blood Cancer Institute	Denver	Colorado
Georgetown University Medical Center	Washington D.C.	District of Columbia
Sylvester Comprehensive Cancer Centre	Miami	Florida
Moffitt Cancer Center	Tampa	Florida
Ann& Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
University of Chicago Medical Center Clinical Laboratories	Chicago	Illinois
Loyola University Medical Center	Maywood	Illinois
University of Iowa	Iowa City	Iowa
The University of Kansas Cancer Center Westwood	Westwood	Kansas
University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
Dana-Farber Cancer Institute	Boston	Massachusetts
Karmanos Cancer Center Institute	Detroit	Michigan
Washington University	St Louis	Missouri
University of Nebraska	Omaha	Nebraska
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
Roswell Park Cancer Institute	Buffalo	New York
Ichann School of Medicine at Mount Sinai	New York	New York
Columbia University Medical Center	New York	New York
Memorial Sloan-Kettering Cancer Center	New York	New York
University of Rochester Medical Center	Rochester	New York
Mayo Clinic	Rochester	New York
Montefiore Medical Center	The Bronx	New York
DUHS-Duke Blood Cancer Center	Durham	North Carolina
Cleveland Clinic	Cleveland	Ohio
James Cancer Hospital and Solove Research Institute	Columbus	Ohio
The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
Fox Chase Cancer Center	Philadelphia	Pennsylvania
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
Prisma Health Cancer Institute	Greenville	South Carolina
Tennessee Oncology, PLLC	Nashville	Tennessee
Vanderbilt University	Nashville	Tennessee

+ 51 more sites — see the full list on the official registry below.

On this site

📄 Yescarta (axicabtagene ciloleucel) drug profile →

More Kite, A Gilead Company trials in Japan

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma Active, not recruiting

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma Active, not recruiting

Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy Recruiting

Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia Active, not recruiting

Other trials for the same condition

X-linked Moesin Associated Immunodeficiency Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05041309 on ClinicalTrials.gov ↗ ← All trials in Japan