Trials / Recruiting
RecruitingNCT05822427
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (estimated)
- Sponsor
- Imugene Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2020-08-25
- Primary completion
- 2039-12-01
- Completion
- 2039-12-01
- First posted
- 2023-04-20
- Last updated
- 2025-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05822427. Inclusion in this directory is not an endorsement.