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NCT06798298 · ClinicalTrials.gov registry record
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
A clinical trial of Long Term Safety Following GM T Cell Therapy, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT06798298: Recruiting study of Long Term Safety Following GM T Cell Therapy, sponsored by Regeneron Pharmaceuticals.
NCT06798298 is a study of Long Term Safety Following GM T Cell Therapy that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798298, a study of Long Term Safety Following GM T Cell Therapy, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- GENETIC Non-interventional
Study Locations (1)
Tennessee
- Tennessee Oncology - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-11-10 |
| Est. Completion | 2040-06-17 |
What NCT06798298 shows while recruiting
NCT06798298 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Long Term Safety Following GM T Cell Therapy appearing as the primary indexed condition, and to 1 intervention - of which Non-interventional is the first listed.
NCT06798298 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06798298 about?
NCT06798298 is a clinical study titled "A Safety and Efficacy Long-Term Follow-up Study of Adult 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...
What is the current status of trial NCT06798298?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-11-10. Estimated completion is 2040-06-17.
What conditions does trial NCT06798298 study?
This clinical trial studies the following conditions: Long Term Safety Following GM T Cell Therapy.
What interventions are being tested in trial NCT06798298?
The interventions under investigation include: Non-interventional (GENETIC).
Who is sponsoring clinical trial NCT06798298?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798298 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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