A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1-positive Tumors of Digestive System

Summary

Transmembrane 4 L Six Family Member 1 (TM4SF1) is highly expressed in many tumors of digestive system . The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 has been generated in our good manufacturing practices (GMP) facility and the anti-tumor effects have been demonstrated in multiple in vitro and in vivo studies. Clinical studies are proposed here to evaluate the anti-tumor activity of these cell therapy products for treatment of patients with TM4SF1 positive tumors of digestive system. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 cells will be examined in patients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or liver cancer. Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.

Timeline

Start

2023-01-30

Primary completion

2024-07-30

Completion

2025-01-30

Publications

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• Background Park YR, Kim SL, Lee MR, Seo SY, Lee JH, Kim SH, Kim IH, Lee SO, Lee ST, Kim SW. MicroRNA-30a-5p (miR-30a) regulates cell motility and EMT by directly targeting oncogenic TM4SF1 in colorectal cancer. J Cancer Res Clin Oncol. 2017 Oct;143(10):1915-1927. doi: 10.1007/s00432-017-2440-4. Epub 2017 May 20.
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Indications