Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.

Phase 1

• Conditions: Gastric Cancer
• Interventions: Biological: MUC1-gene-DC-CTL; Biological: MUC1-peptide-DC-CTL

• Registration Number: NCT02602249
• Lead Sponsor: Beijing Doing Biomedical Co., Ltd.

Brief Summary

In this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human gastric cancer are going to be investigated.

Detailed Description

PBMC of the patient will be separated from peripheral blood.DCs infected by MUC1 and pulsed by MUC-1 peptide are made respectively from PBMC, then they are respectively cultured with T cells into MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL which will be infused to the patients as immunotherapy.

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05
• Study Start: 2017-10
• Primary Completion: 2019-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Sex: male or female

• Age: from 18 to 80 years

• Histology: gastric cancer

• Clinical stage: stage IV

• Karnofsky performance status: more than 50%

• Expected survival: more than 2 months

• Laboratory tests results 7 days before the start of treatment:

  • White blood cells: more than 3.0 × 109/L
  • Platelets: more than 100 × 109/L
  • Neutrophils: more than 1.5 × 109/L
  • Hemoglobin: more than 80g/L
  • Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
  • Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
  • Serum bilirubin: less than 1.25 × ULN
  • Serum creatinine: less than 1.25 × ULN

• Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment

• Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study

• Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria

• History of neoplasms: other neoplasms
• Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
• Metastasis: clinical symptoms of brain metastasis
• Other clinical trial: the subject received other clinical trial before this study
• Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
• Woman: pregnant or lactating women
• Compliance: poor compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group B	MUC1-gene-DC-CTL	MUC1-gene-DC-CTL will be used against tumor cells.
Experimental Group C	MUC1-peptide-DC-CTL	MUC1-peptide-DC-CTL will be used against tumor cells.

Primary Outcome Measures

Name	Time	Method
Reduced size of the tumor.	up to one year	Tumor load will be evaluated by RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Safety, as measured by the rate of adverse events and serious adverse events	up to two years	Safety, as measured by the rate of adverse events and serious adverse events

Trial Locations

Locations (3)

First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Huai'An First People'S Hospital; 🇨🇳 Huaian, Jiangsu, China

Beijing DOING Biomedical Co., Ltd; 🇨🇳 Beijing, China