Advanced Gastric CancerPhase 1NCT03393416
A Phase I Clinical Study for Evaluating the Safety of MASCT-I in Advanced Soild Tumor
A Phase 1 study testing MASCT-I and PD1 antibody in people with Advanced Gastric Cancer, run by HRYZ Biotech Co. at 1 site in China.
Trial summary
This study evaluate the safety and tolerance of MASCT-I(multiple-antigen specific cell therapy) combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- MASCT-I and PD1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2018to Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is 18-70 years old.
- The written informed consent of the patient / legal representative is obtained before any program related implementation.
- Metastatic or non resectable, locally advanced gastric or gastroesophageal adenocarcinoma, confirmed by histology or cytology.
- The development of objective imaging after first-line chemotherapy (RECIST1.1);
- There were measurable lesions (according to RECIST1.1);
- Can provide tumor tissue specimens;
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- PDL1 positive (only for the second, third stage) or MSI test positive;
- Time interval to last chemotherapy is at least 1 month.
- 0-1 ECOG score
- The expected survival time is more than 4 months
- Peripheral blood cell culture showes the proliferation of lymphocytes
Who cannot join
- Participate in the plan or implementation of the research (including staff of HRYZ and the staff of the research center);
- Participate into other clinical studies at the same time, unless it is an observational (non - intervention) clinical study;
- Subjects may receive other systemic antitumor treatment during the study.
- Squamous or undifferentiated gastric cancer
- There were active bleeding, ulcers, gastrointestinal perforation, fistula, or arterial embolism in the gastrointestinal tract within 6 months.
- There were clinically significant gastrointestinal bleeding or venous thrombosis in three months before enrollment.
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- End-stage cachexia patients;
- Patients with severe coagulation dysfunction;
- Patients with extensive abdominal adhesions;
- Patients with intestinal obstruction;
- Pregnancy or planned pregnancy;
- Refusing to provide blood specimens;
- Hypersensitivity to sodium citrate;
- Subjects have received allogeneic transplantation
- Subjects had clinical symptoms of central nervous system metastasis (such as brain edema, requiring hormone intervention, or progression of brain metastases)
- Subjects are using immunosuppressive agents, or whole body or absorbable local hormone therapy to achieve the aim of immunosuppression (dose >10mg/ days prednisone or other therapeutic hormones) and continue to use in the first 2 weeks before enrollment.
- Systemic or long-term application of immunomodulators, such as interferon, thymosin, and immunosuppressive drugs, in half a year.
- Subjects had been treated with MASCT or other cellular immunotherapy within a year.
- Subjects had any active autoimmune disease or a history of autoimmune disease.
- Active tuberculosis
- There is a big operation in 30 days before the first study treatment.
- Patients with active hepatitis B virus (HBV) infection (chronic or acute)
- The infection of active hepatitis C virus (HCV)
- Suffering from human immunodeficiency virus (HIV) or syphilis
- A history of peripheral nervous system disorder or a history of obvious mental disorders and central nervous system disorders
- Subjects had active infection or >38.5 degree of unexplained fever in the screening period and before the first administration.
- Chronic systemic diseases, such as liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease, or non controlled diabetes, hypertension, etc.
- There were other malignant tumors in 5 years, except for non melanin skin cancer and cervical carcinoma in situ
- There are heart symptoms or diseases that have not been well controlled.
- Subjects were known to have a history of psychotropic drug abuse, alcoholism, or drug abuse.
- According to the researchers, there are other factors that may lead to a halt.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
aimin Zhu, Master, 13901216489, zhuaimin@shhryz.com
About this study
Official title: A Single Center, Phase I Clinical Study to Evaluate the Safety of MASCT-I Combined With PD1 Antibody in Vivo for the Advanced Soild Tumor Including Gastric Cancer，Triple-negative Breast Cancer and Ovarian Cancer
This study evaluate the safety and tolerance of MASCT-I(multiple-antigen specific cell therapy) combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy. The study is divided into three stages: the first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The patients would be treated with MASCT-I single drug therapy, MASCT-I+ low dose PD1 antibody therapy, and MASCT-I+ high dose PD1 antibody therapy.
Read the detailed description
The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is optimized continuously and has been upgraded from the first-generation MASCT technology to MASCT-I. MASCT-I is to add PD1 antibody in vitro cell culture process of MASCT technology to block PD1 receptor on immunocytes, relieving the brake at immunocytes' reinfusion and interaction with tumor cells for enhancing the effectiveness of immunocytes killing tumor cells.
This is a phase I study to evaluate the safety and tolerance of MASCT-I combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy.
About 19-28 cases patients with advanced gastric cancer are to be recruited.
This study is divided into three stages:
The first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The first stage is MASCT-I, using 3+3 design, if the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells,the experiment will be end. If the DLT<33.3%, enter the second stage. The second stage is divided into two groups: MASCT-I+PD1 antibody in low dose group and MASCT-I+PD1 antibody in high dose group, using 3+3 design, if all patients in low dose group, the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells, the experiment will be end. If DLT<33.3% began high dose group. If all the patients in the high dose group, DLT ≥33.3%, the corresponding high dose group treatment will be terminated, entered the third stage, the dose of expansion, only by low dose treatment group of 10 patients of reentry. If all the patients in the high dose group, DLT<33.3%, entered the third stage. Only 10 patients in the high dose group were treated with the corresponding high-dose group.
- Conditions
- Advanced Gastric Cancer
- Being tested
- MASCT-I, PD1 antibody
- Keywords
- MASCT-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASCT-IBiological
The final products of MASCT-I(Multiple-antigen specific cell therapy) technology are dendritic cells (DC) and effector T cells.Treatment with MASCT-I alone, conducted until disease progression, intolerance or end of study.
PD1 antibodyDrug
Also called SHR-1210
Drug: PD1 antibody
1mg/kg or 3mg/kg. Administration is conducted in Day1 and Day15. Conducted until disease progression, intolerance or end of study.
| Study group | Role | What they receive |
|---|---|---|
| MASCT-I or MASCT-I +PD1 antibody | Experimental | This study is divided into three stages:
The first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The first stage is MASCT-I, using 3+3 design. The second stage is divided into two groups: MASCT-I+PD1 antibody in low dose group and MASCT-I+PD1 antibody in high dose group, using 3+3 design. The third stage is the dose expansion stage , 10 patients in the low or high dose group were treated with the corresponding dose group. Receives: Biological: MASCT-I; Drug: PD1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events（Safety）
All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients obtained in 14 days after the first treatment cycle of the first course of treatment in this study
Measured: The first 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start19 Apr 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HRYZ Biotech Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Jiafu JI, Doctor, Principal investigator, Cancer Hospital Affiliated to Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393416
- Sponsor's protocol ID
- MASCT-I-1003
- Status last verified
- Aug 2019
- First submitted
- 27 Dec 2017
- Last updated
- 29 Aug 2019
- Results posted
- 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 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Phase I Clinical Study to Evaluate the Safety of MASCT-I Combined With PD1 Antibody in Vivo for the Advanced Soild Tumor Including Gastric Cancer，Triple-negative Breast Cancer and Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03393416
- Acronym / sponsor ID
- MASCT-I-1003
- Conditions
- Advanced Gastric Cancer
- Keywords
- MASCT-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- HRYZ Biotech Co.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 8 Jan 2018 (actual)
- 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.
This study evaluate the safety and tolerance of MASCT-I(multiple-antigen specific cell therapy) combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy. The study is divided into three stages: the first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The patients would be treated with MASCT-I single drug therapy, MASCT-I+ low dose PD1 antibody therapy, and MASCT-I+ high dose PD1 antibody therapy.
Detailed description
The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is optimized continuously and has been upgraded from the first-generation MASCT technology to MASCT-I. MASCT-I is to add PD1 antibody in vitro cell culture process of MASCT technology to block PD1 receptor on immunocytes, relieving the brake at immunocytes' reinfusion and interaction with tumor cells for enhancing the effectiveness of immunocytes killing tumor cells.
This is a phase I study to evaluate the safety and tolerance of MASCT-I combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy.
About 19-28 cases patients with advanced gastric cancer are to be recruited.
This study is divided into three stages:
The first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The first stage is MASCT-I, using 3+3 design, if the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells,the experiment will be end. If the DLT<33.3%, enter the second stage. The second stage is divided into two groups: MASCT-I+PD1 antibody in low dose group and MASCT-I+PD1 antibody in high dose group, using 3+3 design, if all patients in low dose group, the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells, the experiment will be end. If DLT<33.3% began high dose group. If all the patients in the high dose group, DLT ≥33.3%, the corresponding high dose group treatment will be terminated, entered the third stage, the dose of expansion, only by low dose treatment group of 10 patients of reentry. If all the patients in the high dose group, DLT<33.3%, entered the third stage. Only 10 patients in the high dose group were treated with the corresponding high-dose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASCT-I or MASCT-I +PD1 antibody | Experimental | Biological: MASCT-I, Drug: PD1 antibodyThis study is divided into three stages: The first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The first stage is MASCT-I, using 3+3 design. The second stage is divided into two groups: MASCT-I+PD1 antibody in low dose group and MASCT-I+PD1 antibody in high dose group, using 3+3 design. The third stage is the dose expansion stage , 10 patients in the low or high dose group were treated with the corresponding dose group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The age is 18-70 years old.
- The written informed consent of the patient / legal representative is obtained before any program related implementation.
- Metastatic or non resectable, locally advanced gastric or gastroesophageal adenocarcinoma, confirmed by histology or cytology.
- The development of objective imaging after first-line chemotherapy (RECIST1.1);
- There were measurable lesions (according to RECIST1.1);
Key exclusion criteria (31 listed)
- Participate in the plan or implementation of the research (including staff of HRYZ and the staff of the research center);
- Participate into other clinical studies at the same time, unless it is an observational (non - intervention) clinical study;
- Subjects may receive other systemic antitumor treatment during the study.
- Squamous or undifferentiated gastric cancer
- There were active bleeding, ulcers, gastrointestinal perforation, fistula, or arterial embolism in the gastrointestinal tract within 6 months.
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 |
|---|---|---|
| MASCT-IThe final products of MASCT-I(Multiple-antigen specific cell therapy) technology are dendritic cells (DC) and effector T cells.Treatment with MASCT-I alone, conducted until disease progression, intolerance or end of study. | Biological | MASCT-I or MASCT-I +PD1 antibody |
| PD1 antibodyAlso: SHR-1210Drug: PD1 antibody 1mg/kg or 3mg/kg. Administration is conducted in Day1 and Day15. Conducted until disease progression, intolerance or end of study. | Drug | MASCT-I or MASCT-I +PD1 antibody |
Primary outcome
Incidence of Treatment-Emergent Adverse Events（Safety）
Time frame: The first 7 weeks
All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients obtained in 14 days after the first treatment cycle of the first course of treatment in this study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- 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.
Jiafu JI, Doctor principal investigator
Cancer Hospital Affiliated to Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MASCT-I and PD1 antibody in people with Advanced Gastric Cancer, run by HRYZ Biotech Co. at 1 site 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 11 inclusion and 31 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Brent XU, Bachelor (+86 13922171358, xuyizhou@shhryz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events（Safety） (time frame: The first 7 weeks). 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 29 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.