Study of High Efficient Killing Cell Therapy for Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer

Detailed Description
-----------------
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.

Official Title
-----------------
Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: HEKT cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients' age from 18 years to 70 years. Patients who have a life expectancy of at least 3 months. pathologically confirmed non-small cell lung cancer. failed in previous standard chemotherapy and targeted therapy. Karnofsky performance status 0-1. adequate organ functions. Exclusion Criteria: Pregnant and lactating women. Patients with T cell lymphoma, syphilis, AIDS or combination Patients with highly allergic or have a history of severe allergies Patients with severe hepatic or renal dysfunction Patients with severe autoimmune disease or who is being treated with immunosuppressive agents Patients with severe infection not controlled or High fever Patients with organ transplantation or waiting for organ transplantation. Patients with brain metastasis Patients with severe coagulopathy (e.g. hemophilia) Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEKT cell<br>Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times. | Biological: HEKT cell<br>* 3 cycles of HEKT cell treatment<br>* Other names: High Efficient Killing Cell Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment | Occurrence of study related adverse events as assessed by CTCAE v4.0 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy: complete response; partial response; stable disease; progression disease; progression free survival. | The efficacy of the treatment is assessed according to (RECIST1.1) | 2 years |