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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:
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
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.
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Disease Response | Up to 15 years | |
| Overall Survival Rate | Up to 15 years | |
| Azer-cel Persistence |
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Inclusion Criteria:
Exclusion Criteria:
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Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Imugene Limited | Contact | 1 984 245 0082 | info@imugene.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science 37, Inc. | Recruiting | Culver City | California | 90230 | United States |
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Unless participants entering the study have three consecutive negative azer-cel persistence tests results when entering the study, participants will undergo persistence testing whilst on study untill three consecutive negative tests are confirmed.
| Up to 15 years |