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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2019

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.

Interventions

  • Biological: MUC1-gene-DC-CTL
    • MUC1-gene-DC-CTL will be used against tumor cells.
  • Biological: MUC1-peptide-DC-CTL
    • MUC1-peptide-DC-CTL will be used against tumor cells.

Arms, Groups and Cohorts

  • 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.
  • Experimental: Experimental Group C
    • MUC1-peptide-DC-CTL will be used against tumor cells.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Safety, as measured by the rate of adverse events and serious adverse events
    • Time Frame: up to two years
    • Safety, as measured by the rate of adverse events and serious adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Doing Biomedical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • li gangyi, master, Study Chair, Beijing Doing Biomedical Co., Ltd.
  • Overall Contact(s)
    • xie yanyun, master, 086-15601041145, yanyun_xie@doingtimes.com

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