Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Duration of Disease Response [Time frame: Up to 15 years]
- Overall Survival Rate [Time frame: Up to 15 years]
- Azer-cel Persistence [Time frame: Up to 15 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Science 37, Inc. — Culver City
Identifiers
NCT: NCT05822427 · PBCAR-LTF