eligibility_summary
Inclusion: Adults 18–75 with advanced, incurable solid tumors after standard therapy failure, tumor tissue or malignant effusion for TRTs, ≥1 measurable lesion, ECOG 0–1, adequate labs/organ function, LVEF≥50%, lung function/SpO2≥93%. Exclusion: severe allergy/irAE, immunodeficiency/autoimmune disease/transplant, ILD, major CV disease or QTc≥450 ms, severe liver disease, uncontrolled effusions/infection, CNS mets, recent trials/immunosuppression/therapy, HIV/syphilis/HBV/HCV, pregnancy/lactation, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: GK01 autologous tumor‑reactive T cells (TRT) — a biological, adoptive cell therapy using TCR‑mediated tumor recognition (TCR T‑cells). Mechanism of action: patient-derived tumor‑reactive T cells are expanded ex vivo and reinfused to recognize peptide antigens on HLA via their T‑cell receptors, activating TCR signaling and cytotoxic effector functions (perforin/granzyme, cytokines) to kill tumor cells. Targets: tumor antigen–HLA complexes on solid tumor cells (gastric, esophageal, cervical, TNBC, NSCLC), engages CD8+/CD4+ T‑cell activation and effector pathways in the tumor microenvironment.