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

Launched by REGENERON PHARMACEUTICALS · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a treatment called gene modified T cell therapy. This therapy uses specially altered immune cells to help the body fight certain diseases. The trial will follow participants who have already received this treatment in previous studies sponsored by 2seventy bio or Regeneron Pharmaceuticals. It aims to understand how these individuals are doing over time after their treatment.

To participate, you must be someone who received at least one infusion of gene modified T cells in a prior study and either completed the follow-up period or stopped participating after at least six months of monitoring. If you join this study, you will undergo regular check-ups that include safety assessments, lab tests, and surveys to share how you feel about your health. It's important for potential participants to understand this process and willingly agree to take part by signing a consent form. This trial is currently not recruiting participants, but it will be an opportunity for those eligible to contribute to valuable research on this innovative treatment.

Gender

ALL

Eligibility criteria

• 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.