Viewing Study NCT02858232


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Study NCT ID: NCT02858232
Status: UNKNOWN
Last Update Posted: 2016-08-11
First Post: 2016-07-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: MASCT-I Treatment for Advanced Solid Tumor
Sponsor: The First People's Hospital of Lianyungang
Organization:

Study Overview

Official Title: A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor
Status: UNKNOWN
Status Verified Date: 2016-07
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: