Neo-MASCT Immunotherapy for Advanced NSCLC.

The First People's Hospital of Lianyungang

Status and phase: Unknown; Phase 2; Phase 1

Conditions: NSCLC Stage IV

Treatments: Biological: Neo-MASCT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03205930

Neo-MASCT

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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) .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neo-MASCT

Experimental group

Description:

Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)

Treatment:

Biological: Neo-MASCT