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| Name | Class |
|---|---|
| Hengrui Yuanzheng Bio-Technology Co., Ltd. | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solid tumor | Experimental | Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MASCT-I | Biological | 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between clinical efficacy and antigen specific immune response | up to 2 years |
Inclusion 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Xiaodong | Contact | +86018961326201 | jxdysy1970@163.com |
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|
| 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 |