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

NCT05822427 | Recruiting

• 1 other identifier: PBCAR-LTF
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Allogeneic chimeric antigen receptor (CAR) T cell products; azer-cel

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Duration of Disease Response

  Up to 15 years

• Overall Survival Rate

  Up to 15 years

• Azer-cel Persistence

  Up to 15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Imugene Limited: lead

Study Sites (1)

Science 37, Inc.

Culver City, California, 90230, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unless participants entering the study have three consecutive negative azer-cel persistence tests results when entering the study, participants will undergo persistence testing whilst on study untill three consecutive negative tests are confirmed.

Central Study Contacts

Clinical Imugene Limited

CONTACT

1 984 245 0082; info@imugene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: August 25, 2020
• Primary Completion (Estimated): December 1, 2039
• Study Completion (Estimated): December 1, 2039
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)