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

JRCT ID: jRCT2013230062

Registered date:11/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Solid and Hematological Malignancies
• Date of first enrollment: 01/01/2024
• Target sample size: 750
• Countries of recruitment: North America,Japan,Canada,Japan,Ausria,Japan,Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Spain,Japan,Switzerland,Japan,UK,Japan,Australia,Japan,Israel,Japan
• Study type: Interventional
• Intervention(s): Subjects who have received gene-modified cells will roll-over into this stud and will be followed up for up to 15 years from the time they received gene-modified cell therapy. Subjects will not receive gene-modified cell therapy in this study.

Outcome(s)

Primary Outcome

Assess the occurrence of the following late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cells:
-Neurologic disorders: type, date of onset, severity, treatment, and date of resolution
-Autoimmune disorders: type, date of onset, severity, treatment, and date of resolution
-Hematologic disorders: type, date of onset, severity, treatment, and date of resolution
-Serious infections (ie, viral, bacterial, or fungal): type, organism, and timing of infection
-Secondary malignancies: time to development of the secondary malignancy, type, location, and staging
Mechanism of RCR/RCL and/or insertional mutagenesis

Secondary Outcome

- Subsequent anti-cancer therapies
- Survival status
- Cause of death
- Evidence of immune reconstitution
- Rates of RCR/RCL

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include criteria

1. The subject must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent or discontinued the parent study and must have completed the minimum duration of follow up assessments in the parent study, as applicable
2. The subject must understand and voluntarily sign an Informed Consent Form and/or an Informed Assent Form prior to any study-related assessments/procedures being conducted
3. In the investigator's judgment, the subject is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

• Exclude criteria: Not Applicable

Related Information

• Primary Sponsor: Asou Hiroya
• Secondary ID(s): NCT05041309,2020-005843-21