MASCT-I Treatment for Advanced Solid Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor

Conditions
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Solid Tumors

Intervention / Treatment
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* Biological: MASCT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solid tumor<br>Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) | Biological: MASCT-I<br>* 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<br>* Other names: Multiple Target Antigen Stimulating Cell Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | clinical response of treatment according to RESIST v1.1 criteria | 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. | up to 2 years | 
| Progression-Free Survival (PFS) | The length of time from enrollment until the time of progression of disease | From enrollment to progression of disease. Estimated about 6 months | 
| Overall Survival (OS) | From enrollment to death of patients | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MASCT-I, Solid Tumors