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NCT04151186

A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell Therapy for the TM4SF1- and EpCAM-positive Recurrent/Refractory Solid Tumors

Study Summary

* Transmembrane 4 L Six Family Member 1 (TM4SF1) and Epithelial cell adhesion molecule (EpCAM) are both highly expressed in many epithelial-derived solid tumors. * The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 or EpCAM have been generated respectively in our good manufacturing practices (GMP) facility and their 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 or EpCAM positive tumors. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 and CART-EpCAM cells will be examined inpatients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or lung cancer. And 9 patients for each cancer will be evaluated. * Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.

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Interventions

TM4SF1- and EpCAM-positive chimeric antigen receptor T-cell therapyBIOLOGICAL
Specification: 30 mL-100 mL, cell density of about (1-10) x10\^6 cells/ml in each bag, number of T-cells about (1-10) x10\^8 cells.) 300 ml for each infusion. Storage: The prepared CAR T-cells are cryopreserved in a preserving medium . This product is manufactured under the current good manufacture practices (cGMP) conditions, with restrictions on chemical components, free from animal- or human-derived components and confirming to the United States Pharmacopeia (USP)\<71\> and \<85\> regulations. Preservation: The frozen CAR T-cells are preserved in the liquid nitrogen transfer tank. Usage: The frozen CAR T-cells are preserved at low temperature and transferred to the bedside. The cells are thawed by 36 degrees centigrade to 38 degrees centigrade. water bath. The frozen cells are gently massaged until complete thawing. Then they are transfused back to the patients intravenously. The transfusion will be finished within 5-10 min.

Study Locations

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Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026