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

First Affiliated Hospital of Chengdu Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Esophageal Carcinoma; Hepatic Carcinoma; Gastric Cancer; Colon Cancer; Prostate Cancer; Pancreatic Cancer

Treatments: Biological: CAR-T cell immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03013712

CARTEPC-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

CAR-T cell immunotherapy

Experimental group

Description:

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

Treatment:

Biological: CAR-T cell immunotherapy