NCT06798298

A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells

A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Long Term Safety Following GM T Cell Therapy

Interventions

Type	Name	Description
GENETIC	Non-interventional	No study drug administered. Long-term follow-up only.

Timeline

• Start date: 2025-11-10
• Primary completion: 2040-06-17
• Completion: 2040-06-17
• First posted: 2025-01-29
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study