A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional.
- Who it may be relevant to
- Registry conditions: Long Term Safety Following GM T Cell Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
Overview
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.
Interventions
- Genetic Non-interventional
No study drug administered. Long-term follow-up only.
Primary outcome measures
- Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy [Time frame: Up to 15 years]
- Persistence of gene modified T cells [Time frame: Up to 15 years]
- Analysis of vector integration sites [Time frame: Up to 15 years]
- Incidence of RCL [Time frame: Up to 15 years]
- Disease progression status [Time frame: Up to 15 years]
- Date of disease progression [Time frame: Up to 15 years]
- Survival status [Time frame: Up to 15 years]
Secondary outcome measures (1)
- Health-Related Quality of Life (HRQoL) Changes [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Tennessee Oncology — Nashville
Identifiers
NCT: NCT06798298 · LTF-01