Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study
- Sponsor
- Imugene Limited
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Outcome of Clinically Significant CEI
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •No unique exclusion criteria apply to this study.
Outcomes
Primary Outcomes
Outcome of Clinically Significant CEI
Time Frame: Up to 15 years
Severity of Clinically Significant CEI
Time Frame: Up to 15 years
Duration of Clinically Significant CEI
Time Frame: Up to 15 years
Frequency of Clinically Significant Clinical Events of Interest (CEI)
Time Frame: Up to 15 years
Secondary Outcomes
- Duration of Disease Response(Up to 15 years)
- Azer-cel Persistence(Up to 15 years)
- Overall Survival Rate(Up to 15 years)