eligibility_summary
Inclusion: adults 18–70 with advanced solid tumors (e.g., NSCLC, mesothelioma) refractory to standard therapy, life ≥3 mo, ECOG 0–1, tumor MSLN >50% membranous and PD-L1+ (biopsy ≤3 y), adequate marrow, liver, renal, coagulation, lung (SaO2 ≥91%), cardiac (LVEF ≥50%), measurable disease, consent, contraception. Exclusion: prior MSLN/gene/T‑cell therapy, active infections (incl. HIV/HBV/HCV/syphilis), immunosuppression, major cardiac/pulmonary disease, CNS mets/disorders, other cancers (limited exceptions), recent therapy (<2 wks), pregnancy/breastfeeding, investigator‑judged unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: αPD1/CTLA-4-MSLN-CAR T cells (BZE2209), an autologous cellular gene therapy/CAR T-cell product made via non-viral plasmid electroporation of CD3+ T cells. Mechanism: T cells express a mesothelin-specific CAR (alpaca VHH binder with CD28 and CD3ζ signaling) for antigen-directed cytotoxicity against MSLN+ tumor cells, and secrete anti-PD-1 nanobody and anti-CTLA-4 antibody to provide local checkpoint blockade. Targets and pathways: tumor cells expressing mesothelin, PD-1/PD-L1 and CTLA-4 inhibitory pathways on T cells to reverse exhaustion, enhance activation and costimulation, and potentially reduce Treg-mediated suppression. Indication: advanced solid tumors with high MSLN and PD-L1 expression. Study: single-arm, open-label, dose-escalation, Early Phase 1 (China).