RecruitingNCT06798298

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

50 participants

Start Date

Nov 10, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • Not applicable.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICNon-interventional

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


Locations(1)

Tennessee Oncology

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06798298