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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2039-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No