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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05822427

Enrollment

Registered

2023-04-20

Start date

2020-08-25

Completion date

2039-12-31

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Overall Survival Rate	Up to 15 years
Azer-cel Persistence	Up to 15 years
Duration of Disease Response	Up to 15 years

Countries

United States

Contacts

Primary ContactClinical Imugene Limited

info@imugene.com1 984 245 0082

Outcome results