Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL T... | NCT02602249

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

NCT02602249

Sponsor

Beijing Doing Biomedical Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 5, 2017Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Gastric Cancer

Interventions

MUC1-gene-DC-CTL
MUC1-peptide-DC-CTL

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2017Estimated

Primary Completion Date

Apr 2019Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Nov 10, 2015

First Submission Date that Met QC Criteria

Nov 10, 2015

First Posted Date

Nov 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2017

Last Update Posted Date

Sep 5, 2017Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group A(control group)	No Intervention	saline infusion and follow up
Experimental Group B	Experimental	MUC1-gene-DC-CTL will be used against tumor cells.	Biological: MUC1-gene-DC-CTL
Experimental Group C	Experimental	MUC1-peptide-DC-CTL will be used against tumor cells.	Biological: MUC1-peptide-DC-CTL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MUC1-gene-DC-CTL	Biological	MUC1-gene-DC-CTL will be used against tumor cells.	Experimental Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduced size of the tumor.	Tumor load will be evaluated by RECIST criteria.	up to one year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
xie yanyun, master	Contact	086-15601041145		yanyun_xie@doingtimes.com
li gangyi, master	Contact	086-13901106501		gangyi_li@doingtimes.com

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms