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

NCT03662477 | Unknown Early Phase 1 DMC

• 1 other identifier: Shenzhen Fifth Hospita
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

NK Cell Mediated Immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detection of immune function

  Before and 3 months after NK cell therapy

• Analysis of tumor biomarker CEA and CA125 levels in serum

  Before and 3 months after NK cell therapy

Other Outcomes (1)

• The endpoints of interest were progression-free survival (PFS).

  The KPS scores were collected pre-treatment and at 12 months post-treatment.

Study Arms (4)

EGFR+NK+

EXPERIMENTAL

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

Biological: NK cells

EGFR+NK-

NO INTERVENTION

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

EGFR-NK+

EXPERIMENTAL

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

Biological: NK cells

EGFR-NK-

NO INTERVENTION

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

Interventions

NK cells 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.

Also known as: randomized

EGFR+NK+; EGFR-NK+

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• The absence of level 3 hypertension, severe coronary disease, myelosuppression, respiratory disease, acute or chronic infection, and autoimmune diseases. -

Sponsors & Collaborators

• Shenzhen Fifth People's Hospital: lead

Study Sites (1)

Shenzhen Luohu Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Interventions

Random Allocation

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

TAO LIU, PHD

CONTACT

13682481027; 13682481027@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: September 7, 2018
• Study Start: January 1, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2021
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)