NCT03205930

Neo-MASCT Immunotherapy for Advanced NSCLC.

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
BIOLOGICAL	Neo-MASCT	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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2017-07-02
• Last updated: 2017-07-05

Locations

1 site across 1 country: China