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First received: January 17, 2023

Clinical Trial: Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products

Study Status: Completed

Recruit Status: RECRUITING

Condition: Relapsed Hematologic Malignancy

Study Type: OBSERVATIONAL


Official Title: Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products

Brief Summary: Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body.With this genetic modification comes risk of undesirable adverse events.Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that…

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