Clinical trial NCT03205930: Neo-MASCT Immunotherapy for Advanced NSCLC.
Official title: A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: NSCLC Stage IV
Lead sponsor: The First People's Hospital of Lianyungang
Sponsor class: OTHER
Collaborators: name: Hengrui Yuanzheng Bio-Technology Co., Ltd.
First posted: 2017-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center single arm clinical study
Primary purpose: TREATMENT

Brief summary: 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: 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 .

Eligibility criteria: Inclusion Criteria:

1. The age is 18 to 80 years old.
2. The failure standard treatment subjects with advanced or relapsed NSCLC.
3. Informed consent of the patient/legal representative was signed.
4. Other anti-cancer treatments are at least one month apart from the study .
5. The eastern cancer cooperative group (ECOG) was rated 0-2.
6. According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
7. 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:

1. Participate in the planning or implementation of the research .
2. In addition to other clinical studies, unless it is an observational clinical study .
3. Being pregnant or planning a pregnancy.
4. Refuse to provide a blood specimen .
5. Allergic to sodium hydroquinone .
6. There is a history of organ transplantation
7. Brain transfer of the active period
8. Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
9. The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
10. Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
11. The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: 1 to 2 years
Secondary outcomes:
measure: Clinical response of treatment according to RESIST v1.1 criteria
timeFrame: 1 to 2 years
measure: Disease Control Rate (DCR) based on RESIST v1.1 criteria.
timeFrame: 1 to 2 years
measure: Progression-Free Survival (PFS) based on RESIST v1.1 criteria.
timeFrame: From enrollment to progression of disease. Estimated about 6 months
measure: Overall Survival (OS) based on RESIST v1.1 criteria.
timeFrame: From enrollment to death of patients
measure: Elispot report
timeFrame: 1 to 2 years
Other outcomes:
Locations:
city: Jiangsu
country: China
facility: Xiaodong Jiang
state: Doctor
Study officials:
References: