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

Recruiting

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

• Registration Number: NCT05822427
• Lead Sponsor: Imugene Limited

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.

Study Timeline

• Study Start: 2020-08-25
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Primary Completion: 2039-12
• Study Completion: 2039-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of Clinically Significant CEI	Up to 15 years
Severity of Clinically Significant CEI	Up to 15 years
Duration of Clinically Significant CEI	Up to 15 years
Frequency of Clinically Significant Clinical Events of Interest (CEI)	Up to 15 years

Secondary Outcome Measures

Name	Time	Method
Azer-cel Persistence	Up to 15 years
Duration of Disease Response	Up to 15 years
Overall Survival Rate	Up to 15 years

Trial Locations

Locations (1)

Science 37, Inc.; 🇺🇸 Culver City, California, United States