Overview
The goal of this study is to collect information on the long-term safety of study participants who received Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in a Precision BioSciences, Inc. (PBI) Clinical Study. The main questions it aims to answer are:
-What were the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
Participants will visit a study center 3 times during the first year, and once per year after that for a physical exam and other assessments to check for CEI.
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 a PBI clinical study involving PBCAR product dosing. This study protocol does not include administration of a PBCAR product; however, subjects may receive investigational products other than a PBCAR product through participation in other clinical studies during the period of this observational study.
Eligibility
Inclusion Criteria:
- Receipt of at least 1 dose of PBCAR product in a PBI 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.