Long-term follow-up of people treated with gene-modified cell therapies
Tracks long-term safety of gene-modified cell treatments in people from Kite studies.
Plain-language title generated from the registry record
Registry title: Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who received gene-modified cell therapy in a Kite-sponsored study, or finished the follow-up period of that study. It checks long-term safety and effect.
- Sex
- All sexes can join.
- Earlier treatment
- People must have received gene-modified cell therapy, or finished the post-treatment follow-up in the earlier Kite study.
Read by machine on 9 November 2026.
Where in Australia
- Peter MacCallum Cancer CentreMelbourne, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kite, A Gilead Company
- Trial code
- NCT05041309EU 2023-507041-28-00
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.