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

NCT06798298 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-11-24

No results posted yet for this study

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

GENETIC

Non-interventional

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2040-06-17
Completion
2040-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798298 on ClinicalTrials.gov