Clinical trial NCT02602249: Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Cancer
Lead sponsor: Beijing Doing Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced size of the tumor.
timeFrame: up to one year
Secondary outcomes:
measure: Safety, as measured by the rate of adverse events and serious adverse events
timeFrame: up to two years
Other outcomes:
Locations:
city: Luoyang
country: China
facility: First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Huaian
country: China
facility: Huai'An First People'S Hospital
state: Jiangsu
city: Beijing
country: China
facility: Beijing DOING Biomedical Co., Ltd
Study officials:
affiliation: Beijing Doing Biomedical Co., Ltd.
name: li gangyi, master
role: STUDY_CHAIR
References: