A Clinical Research Of CAR T Cells Targeting HER2 Positive Cancer

Study Overview

A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

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.

N/A

Breast Cancer
Ovarian Cancer
Lung Cancer
Gastric Cancer
Colorectal Cancer
Glioma
Pancreatic Cancer

BIOLOGICAL: Anti-HER2 CAR-T

TMMU-BTC-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-03-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-17
First Submitted that Met QC Criteria 2016-03-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-03-19
First Posted (ACTUAL) 2016-03-21	Results First Posted N/A	Last Verified 2020-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HER2 positive cancers Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells	BIOLOGICAL: Anti-HER2 CAR-T HER-2-targeting CAR-T cells infusion in HER2 positive cancers

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HER2 positive cancers

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

BIOLOGICAL: Anti-HER2 CAR-T

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

Primary Outcome Measures	Measure Description	Time Frame
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years

Secondary Outcome Measures	Measure Description	Time Frame
Survival time of Anti-HER2 CAR T cells in vivo.	Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.	1 year
Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells	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）.	12 weeks
Maximum tolerated dose (MTD) of HER2 targeted CAR T cells	Determine the maximum tolerated dose of each participant through the grades of side effects.	4 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Cheng Qian, MD,PhD, Southwest Hospital, China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record