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

Beijing Doing Biomedical

Status and phase: Unknown; Phase 1

Conditions: Gastric Cancer

Treatments: Biological: MUC1-gene-DC-CTL; Biological: MUC1-peptide-DC-CTL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02602249

Doing-003

Details and patient eligibility

About

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 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Experimental Group A(control group)

No Intervention group

Description:

saline infusion and follow up

Experimental Group B

Experimental group

Description:

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

Treatment:

Biological: MUC1-gene-DC-CTL

Experimental Group C

Experimental group

Description:

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

Treatment:

Biological: MUC1-peptide-DC-CTL