Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hengrui Yuanzheng Bio-Technology Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Neoantigen (Neo)is a new targets for immune cells,that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood,and 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 study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.
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.
20 failed standard treatment patients with advanced or recurrent NSCLC will be recruited .
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-MASCT | Experimental | Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-MASCT | Biological | The end product of Neo - MASCT technology is DC and CTL cells.DC injection,in each treatment cycle day 8, axillary, inguinal lymph node with subcutaneous injection. CTL cells, in every treatment cycle 21-28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 | 1 to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of treatment according to RESIST v1.1 criteria | Objective Response Rate (ORR) | 1 to 2 years |
| Disease Control Rate (DCR) based on RESIST v1.1 criteria. | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaodong Jiang | Jiangsu | Doctor | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39751937 | Derived | Qiao Y, Hui K, Hu C, Wang M, Sun W, Liu L, Dong C, Jiang X. Efficacy and safety of PD-1 blockade-activated neoantigen specific cellular therapy for advanced relapsed non-small cell lung cancer. Cancer Immunol Immunother. 2025 Jan 3;74(2):60. doi: 10.1007/s00262-024-03906-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Single center single arm clinical study
Not provided
Not provided
Open clinical study
Not provided
| 1 to 2 years |
| Progression-Free Survival (PFS) based on RESIST v1.1 criteria. | 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) based on RESIST v1.1 criteria. | The length of time from enrollment until the time to death | From enrollment to death of patients |
| Elispot report | The relationship between clinical efficacy and antigen specific immune response | 1 to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |