eligibility_summary
Adults 18–70 with advanced solid tumors: mesothelin ≥50% and PD‑L1+, failed/intolerant to standard Tx, ECOG 0–1, >3‑mo survival, measurable disease, adequate marrow/organ function (acceptable counts/LFTs, SaO2≥91%, LVEF≥50%). Exclude: recent anti‑cancer Tx, prior gene/T‑cell Tx, pregnant/lactating, active HBV/HCV/HIV/syphilis or uncontrolled infection, autoimmune/transplant/immunosuppression, major cardiopulmonary disease, CNS disease/metastases, bleeding risk, recent major surgery/trauma, other malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Intervention: BZT2312 “Fast” CAR T cells (autologous, gene‑modified cellular therapy) targeting mesothelin (MSLN) and engineered to secrete PD‑1 nanobodies. - Mechanisms of action: CAR-mediated recognition of MSLN on tumor cells drives T‑cell activation and cytotoxicity, secreted PD‑1 nanobodies locally block the PD‑1/PD‑L1 checkpoint to enhance CAR T persistence/function and counter tumor-induced T‑cell exhaustion. - Cells/pathways targeted: MSLN‑positive tumor cells, PD‑1/PD‑L1 immune checkpoint pathway within the tumor microenvironment (on T cells/tumor or myeloid cells). - Regimen: Single IV infusion post lymphodepletion (cyclophosphamide + fludarabine), dose escalation 5×10^5, 1×10^6, 5×10^6 CAR+ T cells/kg. - Population: Advanced solid tumors with high MSLN expression (≥50%) and PD‑L1 positivity.