eligibility_summary
Adults 18–70 with refractory solid tumors, ECOG 0–1, ≥12‑week survival, evaluable/measurable lesion and biopsiable tumor for TCR screening, adequate marrow, liver, renal, coagulation, feasible PBMC collection and TCR‑T manufacture, contraception. Exclude prior cell/gene therapy, major bleeding risk, uncontrolled/active CNS disease, autoimmune/immunodeficiency, active infections (HIV/HBV/HCV), recent surgery/therapy/live vaccine/steroids, significant cardiac/pulmonary disease, uncontrolled DM/HTN, effusions, pregnancy/lactation, transplant, substance/psychiatric issues, other high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: KSX01‑TCRT injection—an individualized, autologous, gene‑modified cellular immunotherapy (TCR‑T). Patient T cells are engineered ex vivo to express a tumor‑specific T‑cell receptor identified from the patient’s lesion, then reinfused. Mechanism: HLA‑restricted recognition of tumor peptide antigens via the introduced TCR, initiating TCR/CD3 signaling, activation, proliferation, and cytotoxic killing (perforin/granzyme) of tumor cells. Targets: refractory/relapsed solid tumors presenting the selected antigen. Pathways/cells targeted: antigen presentation (MHC class I), TCR signaling, and cytotoxic T‑lymphocyte effector functions, engineered CD8+/CD4+ T cells act on tumor cells.