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NCT Number: NCT05822427

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Science 37, Inc.

Culver City, California, 90230, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of Clinically Significant Clinical Events of Interest (CEI)

    Time frame: Up to 15 years

  2. Severity of Clinically Significant CEI

    Time frame: Up to 15 years

  3. Duration of Clinically Significant CEI

    Time frame: Up to 15 years

  4. Outcome of Clinically Significant CEI

    Time frame: Up to 15 years

Secondary outcomes

  1. Duration of Disease Response

    Time frame: Up to 15 years

  2. Overall Survival Rate

    Time frame: Up to 15 years

  3. Azer-cel Persistence

    Time frame: Up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Imugene Limited

CONTACT

[email protected]

1 984 245 0082

Sponsors and collaborators

Lead sponsor

Imugene Limited

Industry

Registry information

Important dates

Study start
2020
Primary completion
2039
Study completion
2039
First posted
Apr 20, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.