A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

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.

Inclusion Criteria:

1. Relapsed or refractory EpCAM positive cancer.

2. KPS > 60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 18 years to 80 years.

5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.

6. 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.

7. No other serious diseases(autoimmune disease, immunodeficiency etc.).

8. Adequate cardiac function (LVEF ≥ 40%).

9. No other tumors.

10. Patients volunteer to participate in the research.

Exclusion Criteria:

1. Allergic to cytokines.
2. Uncontrolled active infection.
3. Acute or chronic GVHD.
4. MODS.
5. Treated with T cell inhibitor.
6. HIV affected.
7. Pregnancy.