TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently determine an overall response rate in patients with advanced mesothelin-expressing cancers.
- Added: May 3rd, 2019.
- Last updated: May 3rd, 2019.
Primary Outcome Measures
- 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 ]
- 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 ]
- 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
Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: May 3rd, 2019.
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