eligibility_summary
Adults 18–80, ECOG 0–1, life expectancy >3 mo. Refractory/intolerant solid tumors (breast incl HR+/TNBC, NSCLC, GI, urinary, gynecologic) with TROP‑2 IHC ≥50%. PD‑1+ T cells >10% and PBMC apheresis, measurable disease, adequate marrow/liver/renal/coag, contraception and negative pregnancy test, consent. Exclude: active/untreated brain mets, recent PD‑1/L1/Trop‑2 or other therapy, autoimmune, transplant, immunodeficiency, major infection/TB, COPD flare, serious CV/effusion, need anticoag/antiplatelets, prior gene‑modified cells, pregnancy, poor compliance/abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06082557 (Phase 1/2), single-arm, dose-escalation/expansion in advanced solid tumors. Intervention and type: T60c injection—an autologous, genetically modified CAR-T cell therapy. PD-1–positive T cells are isolated from PBMCs and transduced via lentivirus to express a TROP2-directed chimeric antigen receptor (TROP2-CAR) plus an additional “enhanced receptor” (details not specified). One-time IV infusion. Mechanism of action: Engineered T cells bind TROP2 on tumor cells via the CAR, triggering CAR signaling (CD3ζ/costimulation) to activate cytotoxicity and cytokine release, resulting in tumor cell killing. The added “enhanced receptor” is intended to bolster T-cell function/overcome inhibitory signals. Cells/pathways targeted: Tumor cells expressing TROP2 (TACSTD2, IHC ≥50% required), PD-1–related checkpoint axis (via selecting PD-1+ T cells and engineered enhancement), T-cell activation/cytotoxic pathways.