Recruiting

CAR T-Cell

Sponsor:

Imugene Limited

Code:

NCT05822427

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05822427

Start date

Aug 25, 2020

Status verified date

May, 2025

Completion date

Dec, 2039

Anticipated

Primary completion date

Dec, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Frequency of Clinically Significant Clinical Events of Interest (CEI) [ Time Frame: Up to 15 years ]
  • Severity of Clinically Significant CEI [ Time Frame: Up to 15 years ]
  • Duration of Clinically Significant CEI [ Time Frame: Up to 15 years ]
  • Outcome of Clinically Significant CEI [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

Clinical Imugene Limited

1 984 245 0082info@imugene.com

Locations

Science 37, Inc.

Recruiting

Culver City, California, United States, 90230

More Information

Sponsor

Imugene Limited

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Imugene Limited on 2025-05-14.