Gastric CancerPhase 1/2NCT02585908
Safety and Efficacy of γδ T Cell Against Gastric Cancer
A Phase 1/2 study testing CIK, γδ T and CIK and γδ T in people with Gastric Cancer, run by Beijing Doing Biomedical Co., Ltd. at 4 sites in China.
Trial summary
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- CIK, γδ T and CIK and γδ T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2019to Dec 2022
- Phase
- Phase 1/2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:30-75
- Karnofsky performance status >50
- Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Patients who have a life expectancy of at least 12 weeks
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Who cannot join
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
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: γδ T Cell Immunotherapy for Treatment of Gastric Cancer
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.
Read the detailed description
PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.
- Conditions
- Gastric Cancer
- Being tested
- CIK, γδ T, CIK and γδ T
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIKBiological
CIK cells will be used against tumor cells.
γδ TBiological
γδ T cells will be used against tumor cells.
CIK and γδ TBiological
CIK and γδ T cells will be used against tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A(control group) | No intervention | regular treatment and follow up |
| Experimental Group B | Experimental | CIK will be used against tumor cells. Receives: Biological: CIK |
| Experimental Group C | Experimental | γδ T will be used against tumor cells. Receives: Biological: γδ T |
| Experimental Group D | Experimental | CIK and γδ T will be used against tumor cells. Receives: Biological: CIK and γδ T |
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 posted26 Oct 2015 (estimated)
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 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
- NCT02585908
- Sponsor's protocol ID
- Doing-001
- Status last verified
- Sep 2019
- First submitted
- 22 Oct 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- γδ T Cell Immunotherapy for Treatment of Gastric Cancer
- ClinicalTrials.gov ID
- NCT02585908
- Acronym / sponsor ID
- Doing-001
- Conditions
- Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Doing Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Oct 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 γδT cells on human gastric cancer are going to be investigated.
Detailed description
PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A(control group) | No intervention | –regular treatment and follow up |
| Experimental Group B | Experimental | Biological: CIKCIK will be used against tumor cells. |
| Experimental Group C | Experimental | Biological: γδ Tγδ T will be used against tumor cells. |
| Experimental Group D | Experimental | Biological: CIK and γδ TCIK and γδ T will be used against tumor cells. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age:30-75
- Karnofsky performance status >50
- Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Patients who have a life expectancy of at least 12 weeks
Key exclusion criteria (5 listed)
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- Pregnancy
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 |
|---|---|---|
| CIKCIK cells will be used against tumor cells. | Biological | Experimental Group B |
| γδ Tγδ T cells will be used against tumor cells. | Biological | Experimental Group C |
| CIK and γδ TCIK and γδ T cells will be used against tumor cells. | Biological | Experimental Group D |
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 13 Nov 2019.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CIK, γδ T and CIK and γδ T in people with Gastric Cancer, run by Beijing Doing Biomedical Co., Ltd. at 4 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 6 inclusion and 5 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Nov 2019.