eligibility_summary
Inclusion: Adults 18–70 with incurable/metastatic solid tumors post standard therapy, ECOG 0–1, OS>6 mo, adequate marrow/liver/renal function, HLA‑I+, measurable disease, tumor tissue available with a locked tumor‑specific TCR, agree to leukapheresis and contraception. Exclusion: prior ≥3rd‑line chemo, recent other malignancy, active HBV/HCV/HIV, major cardiac/CNS disease, most autoimmune, prior CAR‑T/gene‑modified T cells/recent allo‑SCT, systemic steroids, FEV1/FVC<70%, recent serious infection/major surgery, or DMSO/drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06150365 (China). Intervention: KSX01-TCRT cell therapy—an autologous, gene‑modified TCR-T cell product (biological). Patient T cells are engineered ex vivo to express a personalized T-cell receptor identified from the patient’s tumor and matched to the patient’s HLA-I type, then expanded and reinfused. Mechanism of action: Engineered TCRs recognize tumor-specific intracellular peptides presented on HLA class I (peptide–HLA complex), activating TCR/CD3 signaling in the transferred T cells to mediate cytotoxic killing via perforin/granzyme and cytokine release. Targets: Patient-specific tumor antigens/neoantigens presented by HLA-I on solid tumor cells, requires HLA-I positivity. Key pathways/cells: Antigen processing and presentation (HLA-I), adaptive T-cell immunity (CD8+ predominant), TCR signaling, effector cytotoxic pathways (IFN-γ, TNF, perforin/granzyme). Design: Single-arm, dose escalation/expansion in refractory/relapsed solid tumors.