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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02602249
• Other study ID #: Doing-003
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 10, 2015
• Last updated: September 1, 2017
• Start date: October 2017
• Est. completion date: April 2020

Study information

• Verified date: September 2017
• Source: Beijing Doing Biomedical Co., Ltd.
• Contact: xie yanyun, master
• Phone: 086-15601041145
• Email: yanyun_xie[@]doingtimes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing DOING Biomedical Co., Ltd	Beijing
China	Huai'An First People'S Hospital	Huaian	Jiangsu
China	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Doing Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced size of the tumor.	Tumor load will be evaluated by RECIST criteria.	up to one year
Secondary	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