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

Launched by KITE, A GILEAD COMPANY · Sep 7, 2021

Keywords

ClinConnect Summary

This is a long-term, post-treatment follow-up study designed to learn more about the safety and how long the effects of Kite’s CAR-T cell therapies last. It’s an observational, prospective cohort study (watching people forward in time) that will track up to about 1,000 participants who previously received a gene-modified cell therapy in a Kite-sponsored trial. Enrollment is by invitation, and the study began in December 2021. Eligible people are those who received an infusion of gene-modified cells in a Kite-sponsored parent study, are alive and able to consent, and have completed or exited the post-treatment follow-up as appropriate. The study includes children, adults, and older adults of all sexes. There are no listed exclusion criteria.

Participants should know this study does not give a new treatment. Instead, researchers will follow participants for up to 15 years to monitor long-term safety and the durability of the therapy’s effects. Primary goals focus on late-onset adverse events and late-onset serious adverse events that may be related to the gene-modified cells, as well as growth and pubertal development in pediatric participants. Secondary goals look at time to any further cancer treatments, overall survival, causes of death, and safety topics like the possible presence of certain viruses or gene integration events. The study is sponsored by Kite (a Gilead company) and is FDA-regulated; data sharing with individuals is not planned.

Gender

ALL

Eligibility criteria

• 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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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