NCT02858232

MASCT-I Treatment for Advanced Solid Tumor

A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then 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 previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients. The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.

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. 40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MASCT-I	Dendritic cells(DC) loaded with antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2016-08-08
• Last updated: 2016-08-11