Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
Sponsor: Autolus Limited
ClinicalTrials ID:NCT03628612
This study monitors patients for up to 15 years post-AUTO CAR T cell therapy to assess delayed SAEs, AESIs, RCR/RCL emergence, new malignancies, CAR transgene persistence, and long-term efficacy. Eligible participants must have received AUTO CAR T therapy, consented to follow-up, and comply with study requirements. No new drug is administered.
Patient Parameters
| Parameter | Options |
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Program Overview
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Description
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
Eligibility Criteria
Inclusion Criteria
- Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- Patients must have provided informed consent for long-term follow-up study prior to participation.
- Patients must be able to comply with the study requirements.
Exclusion Criteria
- There are no specific exclusion criteria for this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
| Washington University in St. Louis | 63110 | St Louis | Missouri |
| St David's South Austin Medical Center | 78704 | Austin | Texas |
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