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

Imugene

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05822427

PBCAR-LTF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.