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

Last updated: May 11, 2025
Sponsor: Imugene Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05822427
PBCAR-LTF
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 protocolrequirements.

Exclusion

Exclusion Criteria:

  • No unique exclusion criteria apply to this study.

Study Design

Total Participants: 75
Study Start date:
August 25, 2020
Estimated Completion Date:
December 31, 2039

Study 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.

Connect with a study center

  • Science 37, Inc.

    Culver City, California 90230
    United States

    Active - Recruiting

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