Effect of NK Cell Immunotherapy on Advanced Lung Adenocarcinoma Adenocarcinoma With EGFR Mutation

NK Cell Mediated Immunity Clinical Trial

Official title:

Effect of Autologous NK Cell Immunotherapy on Advanced Lung Adenocarcinoma With EGFR Mutation: a Preliminary Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662477
• Other study ID #: Shenzhen Fifth Hospita
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2019
• Source: Shenzhen Fifth People's Hospital
• Contact: TAO LIU, PHD
• Phone: 13682481027
• Email: 13682481027[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• NK Cell Mediated Immunity

Intervention

Biological:
• NK 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.

Locations

Country	Name	City	State
China	Shenzhen Luohu Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Fifth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The endpoints of interest were progression-free survival (PFS).	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.	The KPS scores were collected pre-treatment and at 12 months post-treatment.
Primary	Clinical response	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).	Calculated the sum area of all tumors 3 months after NK treatment
Secondary	Detection of immune function	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.	Before and 3 months after NK cell therapy
Secondary	Analysis of tumor biomarker CEA and CA125 levels in serum	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.	Before and 3 months after NK cell therapy