Neo-MASCT Immunotherapy for Advanced NSCLC.

Study Overview
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Brief Summary
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Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.

Detailed Description
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This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase. 20 failed standard treatment patients with advanced or recurrent NSCLC will be recruited .

Official Title
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A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.

Conditions
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NSCLC Stage IV

Intervention / Treatment
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* Biological: Neo-MASCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age is 18 to 80 years old. The failure standard treatment subjects with advanced or relapsed NSCLC. Informed consent of the patient/legal representative was signed. Other anti-cancer treatments are at least one month apart from the study . The eastern cancer cooperative group (ECOG) was rated 0-2. According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion . The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 ^ 9 / L;Platelet ≧ 50 x10 ^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit; Exclusion Criteria: Participate in the planning or implementation of the research . In addition to other clinical studies, unless it is an observational clinical study . Being pregnant or planning a pregnancy. Refuse to provide a blood specimen . Allergic to sodium hydroquinone . There is a history of organ transplantation Brain transfer of the active period Immunosuppressant drugs are currently in use or within 14 days prior to treatment. The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) . Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent . The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single center single arm clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neo-MASCT<br>Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT) | Biological: Neo-MASCT<br>* The end product of Neo - MASCT technology is DC and CTL cells.DC injection,in each treatment cycle day 8, axillary, inguinal lymph node with subcutaneous injection. CTL cells， in every treatment cycle 21-28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 | 1 to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response of treatment according to RESIST v1.1 criteria | Objective Response Rate (ORR) | 1 to 2 years | 
| Disease Control Rate (DCR) based on RESIST v1.1 criteria. | Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). | 1 to 2 years | 
| Progression-Free Survival (PFS) based on RESIST v1.1 criteria. | The length of time from enrollment until the time of progression of disease | From enrollment to progression of disease. Estimated about 6 months | 
| Overall Survival (OS) based on RESIST v1.1 criteria. | The length of time from enrollment until the time to death | From enrollment to death of patients | 
| Elispot report | The relationship between clinical efficacy and antigen specific immune response | 1 to 2 years |