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.
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 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Xiaodong Jiang
Jiangsu, Doctor, China
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
Time frame: 1 to 2 years
Clinical response of treatment according to RESIST v1.1 criteria
Objective Response Rate (ORR)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: From enrollment to death of patients
Elispot report
The relationship between clinical efficacy and antigen specific immune response
Time frame: 1 to 2 years
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