A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
Recruiting now
Conditions studied: Long Term Safety Following GM T Cell Therapy
In brief
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.
Key facts
- Study ID
- NCT06798298
- Run by
- Regeneron Pharmaceuticals
- People needed
- 50
- Starts
- 2025-11-10
- Expected to finish
- 2040-06-17
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Not applicable.
Where it is running
- Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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