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.
Study Type
OBSERVATIONAL
Enrollment
50
No study drug administered. Long-term follow-up only.
Tennessee Oncology
Nashville, Tennessee, United States
RECRUITINGIncidence 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
To assess long-term efficacy following treatment with gene modified T cells
Time frame: Up to 15 years
Date of disease progression
Time frame: Up to 15 years
Survival status
Time frame: Up to 15 years
Health-Related Quality of Life (HRQoL) Changes
Assessed using instruments administered in the parent treatment protocol
Time frame: Up to 5 years
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