Clinical trialObsCompleted
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- 7 October 2022
- Expected end
- 20 April 2025
- Enrollment
- 8 participants
- Sites
- 1
- Primary outcomes
- To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells; To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
- Sponsor
- Industry
- Results posted
- No
- Last update
- 15 October 2026
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Brief summary public domain (ClinicalTrials.gov)
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors
Detailed description public domain (ClinicalTrials.gov)
This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs). Follow-up ended after 7 deaths were reported; 1 participant met the study criteria for lack of cell persistence. No participant remained in follow-up at the 06 July 2025 reporting cutoff.