A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer (CARTEPC)

The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

This study is being conducted to evaluate the safety and efficacy of Chimeric antigen receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In the research, the investigators design a novel CAR consists of a EpCAM targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. The infusion dose is (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Colon Cancer, Esophageal Carcinoma, Pancreatic Cancer, Prostate Cancer, Gastric Cancer, Hepatic Carcinoma

Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.

This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.

Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1

Inclusion Criteria: Relapsed or refractory EpCAM positive cancer. KPS > 60. Life expectancy>3 months. Gender unlimited, age from 18 years to 80 years. Assessable lesions with a minimum size of 10mm by CT scan or MRI. Acceptable organ function Hematology: Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim. White blood cell (WBC) (> 2000/mm^3). Platelet count greater than 50,000/mm^3. Hemoglobin greater than 9.0 g/dl. No other serious diseases(autoimmune disease, immunodeficiency etc.). Adequate cardiac function (LVEF ≥ 40%). No other tumors. Patients volunteer to participate in the research. Exclusion Criteria: Allergic to cytokines. Uncontrolled active infection. Acute or chronic GVHD. MODS. Treated with T cell inhibitor. HIV affected. Pregnancy.