Home › Blood Cancers › NCT05713214
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years. Exclusion Criteria: * Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
About the study
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 meet defined criteria. This protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a St. Jude initiated study.
Sponsor: St. Jude Children's Research Hospital · Participants: 500 · Started: Feb 8, 2023
Contact the study team
- Aimee Talleur, MD · Phone: 866-278-5833
Official record on ClinicalTrials.gov — NCT05713214
Locations in the U.S.
| Tennessee | St. Jude Children's Research Hospital, Memphis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.