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Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment

NCT04567069 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-09-28

No results posted yet for this study

Summary

The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7.

Conditions

Interventions

BIOLOGICAL

DC vaccine

Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection. Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time. Injection site: inguinal lymph nodes.

BIOLOGICAL

CTL

Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.

DRUG

Sintilimab Injection

The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。

Sponsors & Collaborators

  • Shandong Sunstem Biotechnology Co.,Ltd.

    collaborator UNKNOWN

  • The Second Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567069 on ClinicalTrials.gov