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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MUC1-gene-DC-CTL
MUC1-peptide-DC-CTL
Sponsored by
Beijing Doing Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Affiliated Hospital of Henan University of Science and Technology
  • Huai'An First People'S Hospital
  • Beijing DOING Biomedical Co., Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Experimental Group A(control group)

Experimental Group B

Experimental Group C

Arm Description

saline infusion and follow up

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

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

Outcomes

Primary Outcome Measures

Reduced size of the tumor.
Tumor load will be evaluated by RECIST criteria.

Secondary Outcome Measures

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

Full Information

First Posted
November 10, 2015
Last Updated
September 1, 2017
Sponsor
Beijing Doing Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02602249
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Doing Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group A(control group)
Arm Type
No Intervention
Arm Description
saline infusion and follow up
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
MUC1-gene-DC-CTL will be used against tumor cells.
Arm Title
Experimental Group C
Arm Type
Experimental
Arm Description
MUC1-peptide-DC-CTL will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
MUC1-gene-DC-CTL
Intervention Description
MUC1-gene-DC-CTL will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
MUC1-peptide-DC-CTL
Intervention Description
MUC1-peptide-DC-CTL will be used against tumor cells.
Primary Outcome Measure Information:
Title
Reduced size of the tumor.
Description
Tumor load will be evaluated by RECIST criteria.
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Safety, as measured by the rate of adverse events and serious adverse events
Description
Safety, as measured by the rate of adverse events and serious adverse events
Time Frame
up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xie yanyun, master
Phone
086-15601041145
Email
yanyun_xie@doingtimes.com
First Name & Middle Initial & Last Name or Official Title & Degree
li gangyi, master
Phone
086-13901106501
Email
gangyi_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li gangyi, master
Organizational Affiliation
Beijing Doing Biomedical Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Huai'An First People'S Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Beijing DOING Biomedical Co., Ltd
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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