Long-term Follow-up Study for Patients Treated with Genetically Modified T Cells
Sponsor: Autolus Limited
ClinicalTrials ID:NCT03628612
This study is designed to monitor patients who have received a specific type of gene therapy using their own modified T cells, for up to 15 years after their initial treatment. The goal is to understand the long-term effects and safety of this therapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to keep track of patients who have undergone a treatment involving genetically modified T cells, known as AUTO CAR T cell therapy, for up to 15 years. Researchers will be looking for any delayed side effects, new health issues, or changes in the effectiveness of the treatment over time. This long-term monitoring will help determine the overall safety and benefits of the therapy.
Description
This study focuses on following patients who have received AUTO CAR T cell therapy, a treatment that uses a patient's own T cells that have been genetically modified to fight cancer. Over the course of up to 15 years, researchers will monitor these patients to check for any long-term side effects, such as serious adverse events or new health conditions that might arise from the treatment. They will also look for any signs of new viruses or cancers that could be linked to the therapy. Additionally, the study will assess how long the modified T cells remain active in the body and how effective they continue to be in fighting cancer. This information will help doctors better understand the risks and benefits of AUTO CAR T cell therapy in the long run.
Eligibility Criteria
Inclusion Criteria
- Must have received AUTO CAR T cell therapy as part of a clinical study.
- Must have agreed to participate in this long-term follow-up study by providing informed consent.
- Must be able to meet the study's 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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