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

NCT ID: NCT03662477

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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NK Cell Mediated Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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EGFR+NK+

The EGFR mutation positive patients were with the principles of randomized and NK cells treatment.

Group Type EXPERIMENTAL

NK cells

Intervention Type BIOLOGICAL

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.

EGFR+NK-

The EGFR mutation positive patients were with the principles of randomized and without NK cells treatment .

Group Type NO_INTERVENTION

No interventions assigned to this group

EGFR-NK+

The EGFR mutation negative patients were with the principles of randomized and NK cells treatment .

Group Type EXPERIMENTAL

NK cells

Intervention Type BIOLOGICAL

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.

EGFR-NK-

The EGFR mutation negative patients were with the principles of randomized and without NK cells treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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randomized

Eligibility Criteria

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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. -
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Fifth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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LiuTao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenzhen Luohu Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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TAO LIU, PHD

Role: CONTACT

Phone: 13682481027

Email: [email protected]

Facility Contacts

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TAO LIU, PHD

Role: primary

Meiling Zhou, Master

Role: backup

Other Identifiers

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Shenzhen Fifth Hospita

Identifier Type: -

Identifier Source: org_study_id