Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05822427
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2023-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Sponsor:
Imugene Limited
Organization:
Study Overview
Official Title:
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:
* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
* What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
* What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
Detailed Description:
This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: