A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Zhi Yang

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Breast Cancer; Glioma; Gastric Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Biological: Anti-HER2 CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT02713984

TMMU-BTC-005

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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:

   • 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.

   Chemistry:

   • 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).
   • Serum creatinine less or equal to 3 times the upper limit of normal
   • 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

HER2 positive cancers

Experimental group

Description:

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

Treatment:

Biological: Anti-HER2 CAR-T