Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

Primary Outcome Measures

1. Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ]
   
2. Phase 2 – To evaluate the efficacy of autologous genetically modified TC-210 T cells in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate using RECIST v1.1 [ Time Frame: Overall Response Rate at 3 months ]

Inclusion Criteria

• Patient is > 18 years of age at the time the Informed Consent is signed.
• Patient has a pathologically confirmed diagnosis of either Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC).
• Patient’s tumor has been pathologically reviewed by the central laboratory with confirmed positive MSLN expression on > 50% of tumor cells that are 2+ and/or 3+ by immunohistochemistry.
• Prior to TC-210 T cell infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease with more details provided in the clinical protocol
• Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
• Patient has a left ventricular ejection fraction > 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion.
• Patient is fit for leukapheresis and has adequate venous access for the cell collection.
• Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol