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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Clinical Imugene Limited; Phone Number: 1 984 245 0082; Email: info@imugene.com

Study Locations

• United States
  • California
    • Culver City, California, United States, 90230
      • Recruiting
      • Science 37, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Disease Response	Up to 15 years
Overall Survival Rate	Up to 15 years
Azer-cel Persistence	Up to 15 years

Collaborators and Investigators

• Sponsor: Imugene Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): December 1, 2039
• Study Completion (Estimated): December 1, 2039

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Allogeneic chimeric antigen receptor (CAR) T cell products; azer-cel
• Other Study ID Numbers: PBCAR-LTF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No