Actively Recruiting
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Led by St. Jude Children's Research Hospital · Updated on 2025-07-01
1000
Participants Needed
1
Research Sites
1555 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.
You will not qualify if you...
- Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
A
Aimee Talleur, MD
CONTACT
S
Swati Naik, MBBS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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