This study is accepting new patients by invitation only

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

a study on Hematologic Malignancy Autoimmune Disease Hematologic Neoplasms

Summary

Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Solid and Hematological Malignancies, Autoimmune Diseases, Hematologic Neoplasms, axicabtagene ciloleucel, brexucabtagene autoleucel, Anitocabtagene autleucel, KITE-753, KITE-197, KITE-363, INT2104, KITE-512, SPRX001, SPRX002, ARC-T Cells, Axicabtagene Ciloleucel (KTE-C19), Brexucabtagene Autoleucel (KTE-X19), KITE-363: Oncology Indication, KITE-363: Autoimmune Indication, ACLX-001 (SPRX001 + ARC-T cells), ACLX002 (SPRX002 + ARC-T cells)

Eligibility

You can join if…

  • 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

You CAN'T join if...

none

Locations

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Children's Hospital of Orange County
    Orange California 92868 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT05041309
Study Type
Observational
Participants
Expecting 1500 study participants
Last Updated