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

Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With MUC1 Gene(MUC1-gene-DC-CTL) or Directly Pulsed by MUC1 Peptide(MUC1-peptide-DC-CTL) in Gastric Cancer.

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Biological: MUC1-gene-DC-CTL; Biological: MUC1-peptide-DC-CTL

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: xie yanyun, master; Phone Number: 086-15601041145; Email: yanyun_xie@doingtimes.com
• Study Contact Backup: Name: li gangyi, master; Phone Number: 086-13901106501; Email: gangyi_li@doingtimes.com

Study Locations

• China
  • Beijing, China, 100021
    • Beijing DOING Biomedical Co., Ltd
  • Henan
    • Luoyang, Henan, China, 471003
      • First Affiliated Hospital of Henan University of Science and Technology
  • Jiangsu
    • Huaian, Jiangsu, China, 223300
      • Huai'an First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Experimental Group A(control group); saline infusion and follow up
Experimental: Experimental Group B; MUC1-gene-DC-CTL will be used against tumor cells.	Biological: MUC1-gene-DC-CTL; MUC1-gene-DC-CTL will be used against tumor cells.
Experimental: Experimental Group C; MUC1-peptide-DC-CTL will be used against tumor cells.	Biological: MUC1-peptide-DC-CTL; MUC1-peptide-DC-CTL will be used against tumor cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced size of the tumor.	Tumor load will be evaluated by RECIST criteria.	up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, as measured by the rate of adverse events and serious adverse events	Safety, as measured by the rate of adverse events and serious adverse events	up to two years

Collaborators and Investigators

• Sponsor: Beijing Doing Biomedical Co., Ltd.
• Investigators: Study Chair: Li gangyi, master, Beijing Doing Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Doing-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No