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

NCT05713214 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-07-01

No results posted yet for this study

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 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

  • Relapsed Hematologic Malignancy
  • Refractory Hematologic Malignancy

Sponsors & Collaborators

Principal Investigators

  • Aimee Talleur, MD · St. Jude Children's Research Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2052-12-01
Completion
2052-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713214 on ClinicalTrials.gov