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NCT05822427Recruiting

Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study

Imugene Limited

Start Date

8/25/2020

Completion Date

12/1/2039

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study

Locations

Science 37, Inc.

Culver City, California 90230

United States