eligibility_summary
Include: 18–70, driver‑negative NSCLC progressed after ≥2nd‑line incl anti‑PD‑1/L1, ≥1 measurable and ≥1 untreated lesion, ≥2 adequate samples from different lesions, ECOG 0–1, life ≥3 mo, adequate organs, contraception. Exclude: pregnancy/nursing, drug allergy, hepatic encephalopathy, active/uncontrolled CNS mets, liver mets ≥50%, transplant, HIV/syphilis, active HBV/HCV, recent immunosuppression/therapy/surgery/vaccine, poor healing, other cancer <5 y, prior GM cell tx <6 mo, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Single-arm exploratory study in advanced NSCLC testing BST08, an autologous, non-engineered tumor-infiltrating lymphocyte (TIL) cellular therapy, dosed at 9×10^10 cells IV, as monotherapy (Arm A) or combined with pembrolizumab 200 mg Q3W (Arm B). Mechanisms: BST08 comprises ex vivo–expanded, polyclonal patient T cells that recognize tumor antigens through native TCRs and mediate cytotoxicity (perforin/granzyme, cytokines). Pembrolizumab is a humanized IgG4 monoclonal antibody against PD-1, blocking PD-1/PD-L1 signaling to reverse T-cell exhaustion and enhance TIL activity/persistence. Targets: tumor-specific CD8+/CD4+ TILs, TCR–MHC antigen recognition on tumor cells, and the PD-1/PD-L1 pathway in the tumor microenvironment.