eligibility_summary
Adults 18–75 with unresectable locally advanced/metastatic breast cancer with nectin‑4 IHC ≥2+ in ≥50% cells, after failure/intolerance of standard therapy, measurable disease, ECOG 0–1, SpO2 ≥95%, adequate organ function, life expectancy >12 wks, contraception and venous access. Exclude: pregnancy, active HBV/HCV/HIV/syphilis, prior CAR‑T/nectin‑4, recent trials/therapy/steroids/live vaccines/surgery, need immunosuppression, severe allergies, major comorbidities, unresolved toxicities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06724835 evaluates XKDCT293 (Nectin‑4 CAR‑T), an autologous, gene‑modified chimeric antigen receptor T‑cell therapy. Mechanism: patient T cells are engineered ex vivo to express a CAR that binds Nectin‑4 on tumor cells, enabling MHC‑independent recognition, T‑cell activation, cytokine release, and cytotoxic killing. Single‑arm, 3+3 dose‑escalation in Nectin‑4–positive advanced breast cancer after standard therapy, lymphodepleting cyclophosphamide (alkylating) and fludarabine (purine analog) are used pre‑infusion to enhance CAR‑T expansion. Targets: Nectin‑4 (PVRL4) on tumor cells, activation of CAR/TCR signaling (CD3ζ/co‑stimulation) and T‑cell effector pathways leading to tumor lysis. Primary: safety, secondary: kinetics/PD and preliminary efficacy.