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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Biological: MUC1-gene-DC-CTL
* Biological: MUC1-peptide-DC-CTL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |