eligibility_summary
Inclusion: consented adults 18-70 with recurrent/metastatic head & neck cancer after <=2 prior systemic lines, ECOG 0-1, life expectancy >=12 weeks, adequate organ function, prior treatment/lesion records, and >=1 RECIST v1.1 measurable lesion after tumor sampling. Exclusion: uncontrolled tumor pain (unstable analgesics) or unfinished palliative RT, serious mental illness/substance abuse, pregnancy/lactation or planned within 1 year, other trial drugs <=4 weeks before NMA-LD or planned, or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: GT201 (autologous tumor-infiltrating lymphocyte, TIL, infusion, adoptive cellular immunotherapy) plus a PD-1 inhibitor (immune checkpoint monoclonal antibody). Mechanisms: GT201 delivers patient-derived T cells expanded ex vivo to recognize tumor antigens via TCRs, execute antigen-specific cytotoxicity, and secrete effector cytokines (e.g., IFN-γ, TNF-α). The PD-1 inhibitor blocks PD-1 on T cells to prevent PD-1/PD-L1 inhibitory signaling, reverse T-cell exhaustion, and enhance TIL function and persistence. Targets: tumor-reactive CD8+/CD4+ TILs in the tumor microenvironment, PD-1 checkpoint pathway on T cells, TCR-mediated antitumor pathways and downstream effector functions/cytokines. Indication: advanced head and neck malignancies. Primary focus: safety/tolerability, also TIL expansion/kinetics and efficacy (RECIST).