Clinical Trials Directory

Trials / Completed

CompletedNCT05292859

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

Status
Completed
Phase
—
Study type
Observational
Enrollment
7 (actual)
Sponsor
Alaunos Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALNeoantigen specific TCR-T cell drug productNo study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy

Timeline

Start date
2023-03-01
Primary completion
2025-05-30
Completion
2025-05-30
First posted
2022-03-23
Last updated
2025-07-30

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05292859. Inclusion in this directory is not an endorsement.