Gastric CancerPhase 1NCT02602249
Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.
A Phase 1 study testing MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL in people with Gastric Cancer, run by Beijing Doing Biomedical Co., Ltd. at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2017to Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
China3 sites
Beijing DOING Biomedical Co., Ltd
Beijing, 100021
Huai'An First People'S Hospital
Huaian, Jiangsu, 223300
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
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.
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- MUC1-gene-DC-CTL, MUC1-peptide-DC-CTL
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUC1-gene-DC-CTLBiological
MUC1-gene-DC-CTL will be used against tumor cells.
MUC1-peptide-DC-CTLBiological
MUC1-peptide-DC-CTL will be used against tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MUC1-gene-DC-CTL |
| Experimental Group C | Experimental | MUC1-peptide-DC-CTL will be used against tumor cells. Receives: Biological: MUC1-peptide-DC-CTL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced size of the tumor.
Tumor load will be evaluated by RECIST criteria.
Measured: up to one year
Secondary outcomes (1)
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
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Doing Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- li gangyi, master, Study chair, Beijing Doing Biomedical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602249
- Sponsor's protocol ID
- Doing-003
- Status last verified
- Sep 2017
- First submitted
- 10 Nov 2015
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02602249
- Acronym / sponsor ID
- Doing-003
- Conditions
- Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Doing Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A(control group) | No intervention | –saline infusion and follow up |
| Experimental Group B | Experimental | Biological: MUC1-gene-DC-CTLMUC1-gene-DC-CTL will be used against tumor cells. |
| Experimental Group C | Experimental | Biological: MUC1-peptide-DC-CTLMUC1-peptide-DC-CTL will be used against tumor cells. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Sex: male or female
- Age: from 18 to 80 years
- Histology: gastric cancer
- Clinical stage: stage IV
- Karnofsky performance status: more than 50%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUC1-gene-DC-CTLMUC1-gene-DC-CTL will be used against tumor cells. | Biological | Experimental Group B |
| MUC1-peptide-DC-CTLMUC1-peptide-DC-CTL will be used against tumor cells. | Biological | Experimental Group C |
Primary outcome
Reduced size of the tumor.
Time frame: up to one year
Tumor load will be evaluated by RECIST criteria.
1 secondary outcome
Safety, as measured by the rate of adverse events and serious adverse events
Time frame: up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li gangyi, master study chair
Beijing Doing Biomedical Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL in people with Gastric Cancer, run by Beijing Doing Biomedical Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xie yanyun, master (086-15601041145, yanyun_xie@doingtimes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced size of the tumor. (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.