Solid TumorsPhase 1/2NCT02858232
MASCT-I Treatment for Advanced Solid Tumor
A Phase 1/2 study testing MASCT-I in people with Solid Tumors, run by The First People's Hospital of Lianyungang.
Trial summary
Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- MASCT-I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
- With written informed consent signed voluntarily by patients themselves.
- The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
- ECOG≤2.
- At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
- Life expectancy ≥6 months.
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- With normal cardiopulmonary function.
- Patients have adequate organ function as defined by the following criteria:
- Hemoglobin (HGB) ≥85g/L Absolute neutrophil count (ANC) ≥1.0×10^9/L White blood cell (WBC) ≥3.0×10^9/L Platelet count ≥80×10^9/L Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis Alkaline phosphatase (ALP)≤2.5 UNL Total bilirubin (TBil) of ≤1.5 UNL Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL Albumin (ALB) ≥30g/L
Who cannot join
- Pregnant or expecting to pregnant
- Participated in other clinical trials before screening except of observational study.
- Refused to provide blood samples.
- Known allergic history of sodium citrate drugs.
- Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
- Known active brain metastases
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- The use of immunosuppressive drugs with current or 14 days before enrollment.
- Active primary immune deficiency.
- known history of tuberculosis.
- Active infection, including hepatitis B, hepatitis C virus, or human immunodeficiency virus.
- Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
- Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
- Clinical signs of heart disease.
- Treatment with any anti-tumors agent within 28days of first administration of study treatment.
- The research on the influence of non legal persons, medical or ethical reasons
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor
Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.
The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.
Read the detailed description
This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.
40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.
- Conditions
- Solid Tumors
- Being tested
- MASCT-I
- Keywords
- MASCT-I, Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASCT-IBiological
Also called Multiple Target Antigen Stimulating Cell Therapy
Dendritic cells(DC) loaded with antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
| Study group | Role | What they receive |
|---|---|---|
| solid tumor | Experimental | Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) Receives: Biological: MASCT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, versio4.0
Measured: up to 2 years
Secondary outcomes (4)
Objective Response Rate (ORR)
clinical response of treatment according to RESIST v1.1 criteria
Measured: up to 2 years
Disease Control Rate (DCR)
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria.
Measured: up to 2 years
Progression-Free Survival (PFS)
The length of time from enrollment until the time of progression of disease
Measured: From enrollment to progression of disease. Estimated about 6 months
Overall Survival (OS)
From enrollment to death of patients
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Collaborators
- Hengrui Yuanzheng Bio-Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858232
- Sponsor's protocol ID
- LYG1602-01-02
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT02858232
- Acronym / sponsor ID
- LYG1602-01-02
- Conditions
- Solid Tumors
- Keywords
- MASCT-I, Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Collaborators
- Hengrui Yuanzheng Bio-Technology Co., Ltd.
- Study start
- Aug 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Aug 2016 (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.
Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.
The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.
Detailed description
This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.
40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| solid tumor | Experimental | Biological: MASCT-IMultiple Target Antigen Stimulating Cell Therapy (MASCT-I) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
- With written informed consent signed voluntarily by patients themselves.
- The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
- ECOG≤2.
- At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
Key exclusion criteria (15 listed)
- Pregnant or expecting to pregnant
- Participated in other clinical trials before screening except of observational study.
- Refused to provide blood samples.
- Known allergic history of sodium citrate drugs.
- Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
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-IAlso: Multiple Target Antigen Stimulating Cell TherapyDendritic cells(DC) loaded with antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | Biological | solid tumor |
Primary outcome
Incidence of treatment-related adverse events
Time frame: up to 2 years
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, versio4.0
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: From enrollment to progression of disease. Estimated about 6 months
Overall Survival (OS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MASCT-I in people with Solid Tumors, run by The First People's Hospital of Lianyungang.
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 9 inclusion and 15 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Jiang Xiaodong (+86018961326201, jxdysy1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: up to 2 years). 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 11 Aug 2016.