Non Small Cell Lung Cancer
Conditions
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.
Interventions
BIOLOGICALHEKT cell
3 cycles of HEKT cell treatment
Sponsors
Shanghai Houchao Biotechnology Co., Ltd
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment | 2 years | Occurrence of study related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy: complete response; partial response; stable disease; progression disease; progression free survival. | 2 years | The efficacy of the treatment is assessed according to (RECIST1.1) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 years | Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause. |
| Overall survival | 2 years | Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause. |
| Imaging evaluation before and after treatment | 0 day and 60 day | the SUV index of PET-CT before cell injection and after the whole course of the treatment |
Countries
China
Contacts
Primary ContactLei H Du, M.S
Outcome results
None listed