Actively Recruiting
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
Led by Regeneron Pharmaceuticals · Updated on 2025-11-24
50
Participants Needed
1
Research Sites
761 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who received at least one gene modified T cell infusion in a previous 2seventy bio or Regeneron Pharmaceuticals study before April 2024
- Participants who have completed the post-treatment follow-up or at least 6 months of safety monitoring after the gene modified T cell therapy
- Participant or legal representative must understand and voluntarily sign an informed consent or assent form before any study procedures
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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