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

November 21, 2025 updated by: Regeneron Pharmaceuticals

A Long-Term Follow-up Protocol for 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Enrolled participants will be determined by the number of participants participating in GM T cell 2seventy bio (prior to April 2024) and Regeneron Pharmaceuticals sponsored studies consenting to participate in the LTFU study.

Description

Inclusion Criteria:

  1. 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.
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GM T cell population
Participants exposed to gene modified T cell therapy on a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study
Genetic: Non-interventional
No study drug administered. Long-term follow-up only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
Time Frame: Up to 15 years
Up to 15 years
Persistence of gene modified T cells
Time Frame: Up to 15 years
Up to 15 years
Analysis of vector integration sites
Time Frame: Up to 15 years
Up to 15 years
Incidence of RCL
Time Frame: Up to 15 years
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
Up to 15 years
Date of disease progression
Time Frame: Up to 15 years
Up to 15 years
Survival status
Time Frame: Up to 15 years
Up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQoL) Changes
Time Frame: Up to 5 years
Assessed using instruments administered in the parent treatment protocol
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

June 17, 2040

Study Completion (Estimated)

June 17, 2040

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LTF-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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