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
- Fukuoka, Kyoto, Okayama, Sapporo Hokkaido, Sendai, and Tokyo, JapanSee the 6 sites
- Phase
- Phase 2
Where in Japan
- Kyushu University HospitalFukuoka, JapanNo longer taking part
- Kyoto University HospitalKyoto, JapanNo longer taking part
- Okayama University HospitalOkayama, JapanNo longer taking part
- Hokkaido University HospitalSapporo Hokkaido, JapanNo longer taking part
- Tohoku University HospitalSendai, JapanNo longer taking part
- National Cancer Center HospitalTokyo, JapanNo 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.