Tennessee Oncology
Nashville, Tennessee, 37203, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06798298
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.
Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.
Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
- Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.
Exclusion criteria
Not applicable.
Treatment and study plan
Non-Interventional
GeneticNo study drug administered. Long-term follow-up only.
Primary outcomes
-
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
Time frame: Up to 15 years
-
Persistence of gene modified T cells
Time frame: Up to 15 years
-
Analysis of vector integration sites
Time frame: Up to 15 years
-
Incidence of RCL
Time frame: Up to 15 years
-
Disease progression status
Time frame: Up to 15 years
To assess long-term efficacy following treatment with gene modified T cells
-
Date of disease progression
Time frame: Up to 15 years
-
Survival status
Time frame: Up to 15 years
Secondary outcomes
-
Health-Related Quality of Life (HRQoL) Changes
Time frame: Up to 5 years
Assessed using instruments administered in the parent treatment protocol
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Official study title
A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
Important dates
- Study start
- 2025
- Primary completion
- 2040
- Study completion
- 2040
- First posted
- Jan 29, 2025
- Registry last updated
- Jul 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.