Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.
Eligibility Criteria
Inclusion Criteria: * Patients must have a histological or cytological diagnosis of advanced solid tumors, such as non-small-cell lung cancer and mesothelioma； * Patients must have failed established standard medical anti-cancer therapies； * Greater than or equal to 18 years of age and less than or equal to 70 years of age on day of signing informed consent； * Life expectancy ≥3 months； * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1； * Staining of MSLN must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. PD-L1 expression must be positive. Tissue obtained for the biopsy must be ≤3 year prior to enrollment for screening； * Satisfactory organ and bone marrow function as defined by the following: 1. Adequate bone marrow function in the opinion of the Investigator for lymphocyte-depleting chemotherapy: absolute neutrophil count must be greater than ≥ 1.5×10\^9/L, lymphocyte count must be greater than ≥ 0.5×10\^9/L,