NK Cell Mediated Immunity
Conditions
Brief summary
This study was attempted to investigate the efficiency of NK cells immunotherapy on non-small cell lung cancer with and without EGFR mutation, and evaluated response rate (RR) and the progression-free survival (PFS).
Detailed description
Investigators will enrolle 100 patients who met the enrollment criteria. 50 patients were clinically confirmed EGFR mutation positive. They were divided into two groups (group A and group C according to if accepted NK therapy) in accordance with the principles of randomized. The rest 50 patients which were EGFR mutation negative were also divided into two groups (group B and group D) in accordance with the principles of randomized to be paired respectively with group A and group C. Comparison of lymphocyte number, serum tumor related biomarkers, circulating Tumor Cell (CTC), KPS and survival curves was carried out before after NK cell immunotherapy. The safety and short-term effects were evaluated followed by the median PDA, response rate assessment.
Interventions
BIOLOGICALNK cells
NK cells were generated in good manufacturing practice (GMP) condition. In brief, PBMCs were isolated from 50mL patient's blood with Ficoll-Hypaque(Morecell Biomedical Co. Ltd., Shenzhen, China). Then the Human NK Cell Culture Kit (Cat. No. MCF-004, Morecell Biomedical Co. Ltd., Shenzhen, China) and Serum-free Medium for NK Cells (MCM-002, Morecell Biomedical Co. Ltd., Shenzhen, China) was used for induction of NK cells according to the manufacturer's instructions. Three days before NK cell transfusion, the NK cells were sampled and sent to detect the NK cell quality.
Sponsors
Shenzhen Fifth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The criteriaof the enrollment are as following: (1) expected survival\>6 months; (2) age between35-75 years old; (3) KPS \>45; (4) platelets\>80 × 109/L, WBC\>3 × 109/L, hemoglobin\>90g/L, prothrombin time-international normalized ratio (0.8-1.5), adequate hepatic function (bilirubin \< 20 μM, aminotransferase\<60 U/L) and renal function (serum creatinine \< 130 μM, serum urea \<10 mM); (5) All patients confirmed by pathology and/or imaging;
Exclusion criteria
The absence of level 3 hypertension, severe coronary disease, myelosuppression, respiratory disease, acute or chronic infection, and autoimmune diseases. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | Calculated the sum area of all tumors 3 months after NK treatment | Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR),stable disease (SD), progressive disease (PD). Investigators calculated the sum area of all tumors 3 months after NK treatment. The recent curative effect must have been maintainedat \>4 weeks; CR + PR denoted the effective response rate (RR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of immune function | Before and 3 months after NK cell therapy | Patients were detected Lymphocyte subgroups of 1ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell number, CD4T cell number, CD8 T cell number and NK cell number. |
| Analysis of tumor biomarker CEA and CA125 levels in serum | Before and 3 months after NK cell therapy | Patients were detected the Serum Carcinoembryonic antigen (CEA) and CA125 level by Elisa kit.Investigators compared the level of CEA and CA125 in serum before and 3 months after NK cell therapy to perform the therapeutic evaluation. factor to identify patients tumor recurrence.We then compared the level of CEA and CA125 in serum before and 3 months after NK cell therapy to perform the therapeutic evaluation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The endpoints of interest were progression-free survival (PFS). | The KPS scores were collected pre-treatment and at 12 months post-treatment. | Investigators evaluated the Karnofsky Performance Status (KPS) according to the comprehensive assessment of clinical activity, disease level, and self-care ability. Status (KPS) according to the comprehensive assessment of clinical activity, disease level, and self-care ability. |
Countries
China
Contacts
Primary ContactTAO LIU, PHD
Outcome results
None listed