eligibility_summary
Adults ≥18 with consent: advanced lung adenocarcinoma progressing after recurrence or first-line chemo, ECOG 0–1, ≥3‑month life expectancy, adequate organ function, ≥1 measurable lesion (RECIST v1.1). Excludes prior allogeneic transplant/organ graft/engineered cell therapy, prior FOLR1 therapy unless approved, recent (<2 wks) anticancer therapy or systemic steroids, pregnancy/lactation/planned pregnancy within 12 months, CNS, autoimmune, or primary immunodeficiency disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase I, open-label, single-arm, multicenter study in China evaluating GTE-001 for advanced lung adenocarcinoma after progression on prior therapy. Intervention/drug: GTE-001 injection—an autologous tumor-infiltrating lymphocyte (TIL) product (biological, adoptive cellular immunotherapy). Mechanism of action: TILs are isolated from the patient’s tumor, expanded ex vivo, and reinfused to recognize tumor neoantigens/tumor-associated antigens via the T-cell receptor, driving CD8+ cytotoxic killing (perforin/granzyme, IFN-γ) with CD4+ support and potential remodeling of the tumor microenvironment. Targets: Tumor cells presenting antigens via MHC I/II, key immune pathways include TCR signaling, antigen processing/presentation, and cytotoxic lymphocyte effector pathways. Endpoints include safety, preliminary efficacy, manufacturing feasibility, and biomarker correlations.