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RECRUITING
NCT06798298

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-11-10

Completion Date

2040-06-17

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

GENETIC

Non-interventional

No study drug administered. Long-term follow-up only.

Locations (1)

Tennessee Oncology

Nashville, Tennessee, United States