Brief Summary:

Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.

Breast Cancer

Ovarian Cancer

Lung Cancer

Gastric Cancer

Colorectal Cancer

Glioma

Pancreatic Cancer

Biological: Anti-HER2 CAR-T

Arms and Interventions

Arm

Experimental: HER2 positive cancers

Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells

Intervention

Biological: Anti-HER2 CAR-T

HER-2-targeting CAR-T cells infusion in HER2 positive cancers

Primary Outcome Measures  :

1. Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. [ Time Frame: 3 years ]

Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures  :

1. Survival time of Anti-HER2 CAR T cells in vivo. [ Time Frame: 1 year ]

Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.

2. Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells [ Time Frame: 12 weeks ]

Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria（iRECIST）.

3. Maximum tolerated dose (MTD) of HER2 targeted CAR T cells [ Time Frame: 4 weeks ]

Determine the maximum tolerated dose of each participant through the grades of side effects.

Criteria

Inclusion Criteria:

1.     Relapsed or refractory HER2 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:

o   Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.

o   White blood cell (WBC) (> 2000/mm^3).

o   Platelet count greater than 50,000/mm^3.

o   Hemoglobin greater than 9.0 g/dl.

Chemistry:

o   Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).

o   Serum creatinine less or equal to 3 times the upper limit of normal

o   Total bilirubin less than or equal to 3 times the upper limit of normal.

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.     Other situations improper for the research.