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

Recruiting now

Conditions studied: Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT05713214

Run by

St. Jude Children's Research Hospital

People needed

500

Starts

2023-02-08

Expected to finish

2052-12-01

Last updated by the study team

2026-06-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.

You may not qualify if…

• Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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