Long-term safety and effectiveness follow-up after gene-modified T cell treatment in adults
Official title: A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
Run by Regeneron Pharmaceuticals · NCT06798298 · Data updated 2026-11-12
This follows adults who received gene-modified T cell therapy to see whether the treatment stays safe and continues to work over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | June 17, 2040 |
| Study ends | June 17, 2040 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06798298 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who received at least one infusion of gene-modified T cells in a prior Regeneron or 2seventy bio–sponsored protocol and completed or discontinued the parent study after required monitoring are eligible.
✕Probably not a fit
People who never received gene-modified T cell therapy or who cannot attend required follow-up visits are not candidates and would not gain direct benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective long-term follow-up protocol enrolls adults previously treated with gene-modified T cells in Regeneron- or 2seventy bio–sponsored studies. Eligible participants received at least one infusion and have completed or discontinued their parent protocol after the required post-treatment monitoring. The study is non-interventional and collects scheduled safety assessments, laboratory tests, and patient-reported outcome questionnaires over time in accordance with health authority guidance. Follow-up includes monitoring for replication-competent lentivirus and other long-term safety or durability signals.
Why it matters
Potential benefit: If successful, the study could identify long-term safety issues or lasting benefits, helping clinicians counsel and manage future patients treated with gene-modified T cells.
How similar studies have gone: Long-term follow-up programs for gene-modified T cell therapies, including CAR-T products, have previously provided valuable safety and durability data, so this approach builds on established practice.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tennessee Oncology
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.