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

NCT02602249 | Unknown Phase 1

• 1 other identifier: Doing-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Reduced size of the tumor.

  Tumor load will be evaluated by RECIST criteria.

  up to one year

Secondary Outcomes (1)

• Safety, as measured by the rate of adverse events and serious adverse events

  up to two years

Study Arms (3)

Experimental Group A(control group)

NO INTERVENTION

saline infusion and follow up

Experimental Group B

EXPERIMENTAL

MUC1-gene-DC-CTL will be used against tumor cells.

Biological: MUC1-gene-DC-CTL

Experimental Group C

EXPERIMENTAL

MUC1-peptide-DC-CTL will be used against tumor cells.

Biological: MUC1-peptide-DC-CTL

Interventions

MUC1-gene-DC-CTL BIOLOGICAL

MUC1-gene-DC-CTL will be used against tumor cells.

Experimental Group B

MUC1-peptide-DC-CTL BIOLOGICAL

MUC1-peptide-DC-CTL will be used against tumor cells.

Experimental Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Doing Biomedical Co., Ltd.: lead

Study Sites (3)

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Huai'An First People'S Hospital

Huaian, Jiangsu, 223300, China

Location

Beijing DOING Biomedical Co., Ltd

Beijing, 100021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• li gangyi, master

  Beijing Doing Biomedical Co., Ltd.

  STUDY CHAIR

Central Study Contacts

xie yanyun, master

CONTACT

086-15601041145; yanyun_xie@doingtimes.com

li gangyi, master

CONTACT

086-13901106501; gangyi_li@doingtimes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: October 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: September 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)