About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Receipt of at least 1 dose of azer-cel in an Imugene clinical study.
A signed informed consent form (ICF).
Willingness and ability to adhere to the study schedule and all other protocol requirements.
Disqualifiers
No unique exclusion criteria apply to this study.
Trial population
Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Frequency of Clinically Significant Clinical Events of Interest (CEI)
Severity of Clinically Significant CEI
Duration of Clinically Significant CEI
Outcome of Clinically Significant CEI
Secondary outcomes
Duration of Disease Response
Overall Survival Rate
Azer-cel Persistence
Sponsors and contacts
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