eligibility_summary
Eligibility: Prior recipients of Alaunos TCR‑T therapy (treated on TCR001‑201 or another Alaunos TCR‑T trial) who completed or discontinued their parent protocol, able to follow visit schedule, provide informed consent, agree to sample collection/storage. Exclusion: Those consented to this LTFU who did not receive TCR‑T on TCR001‑201, no other exclusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Neoantigen-specific TCR-T cell drug product—an autologous, gene-modified cellular immunotherapy engineered with the Sleeping Beauty transposon/transposase system (non-viral DNA integration) to stably express tumor-reactive T cell receptors. Mechanism of action: infused T cells recognize mutation-derived neoantigen peptides presented on HLA (primarily MHC I), triggering TCR-CD3 signaling and cytotoxic killing (perforin/granzyme) and potential immunologic memory. Targets: tumor cells presenting neoantigens, pathways include antigen processing/presentation and TCR signaling in adaptive immunity. Study: observational long-term follow-up (up to 15 years) after prior dosing, no new drug administered, solid tumors (e.g., CRC, pancreatic, NSCLC, cholangiocarcinoma, ovarian).